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of US
Sixth Edition
Chapter 36

Regulatory Information
By Diane R. Whitworth

OBJECTIVES supporting product substantiation, regulatory review

T Become familiar with print and electronic analysis, strategic planning and increasing professional
information resources relevant to the regulatory knowledge will be assessed.
healthcare industry
Print and Electronic Publications
T Understand how to access and retrieve publicly Print and electronic information resources play an
available, Internet-based government agency essential role in a regulatory professionals ability to gain,
and association resources to support the maintain and advance knowledge and understanding of
regulatory intelligence process various healthcare industry product sectors. The regula-
tory profession is characterized by repeated job changes
T Recognize the value of industry associations to among professionals as well as by frequent mergers
expand professional knowledge and develop among the pharmaceutical, device and biologics com-
regulatory core competencies panies themselves. For example, it is not uncommon for
T Learn how to access selected Web 2.0 tools a regulatory professionals career to begin in the phar-
(blogs and social networks) to increase maceutical industry and transition into the devices area
professional effectiveness due to a job change, a lateral move into another division
within a company or perhaps to a work assignment in
an area that requires an understanding of combination
products. There are many and varied reasons why a pro-
LAWS, REGULATIONS AND GUIDELINES fessional may require additional regulatory information.
COVERED IN THIS CHAPTER Fortunately, available print and electronic tools to fulfill
this requirement are increasingly abundant.
T Federal Register (FR) and Code of Federal
Regulations (CFR) Book Publishers
A number of publishers specialize in print and elec-
Introduction tronic publications focused on healthcare regulatory
Regulatory professionals have significantly improved topics. This section reviews industry, government, asso-
their productivity, effectiveness and expertise in the ciation and standards publishers that target the regula-
workplace through access to the ever-increasing array tory healthcare profession and explains how regulatory
of Internet-based regulatory information resources. professionals can retrieve the most relevant resources
The ease with which regulatory information may now using the publishers online catalogs. Because regulatory
be obtained is profound compared to the days when affairs is an interdisciplinary profession, publishers that
the only way to acquire this documentation was via primarily concentrate on scientific research and develop-
telephone, fax or mail. This chapter provides a detailed ment (R&D), law, medicine, business or government, or
review of a broad range of electronic industry, govern- possibly all of the above, may also feature publications
ment and association resources available to regula- focused specifically on the regulatory aspects of these
tory professionals. The value of each of these tools in subjects.

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Table 36-1. Publisher Resources

Publisher Website Resources

AdvaMed News Alerts (Fee-based)

American Society for Quality index.html Books, Standard, Training
(ASQ Press) Materials & Journals
American Society of Testing books_journals.shtml Books, Standards,
and Materials (ASQM) Technical Publications,
Manuals, Handbooks,
Aspen Publishers Books, Journals &
Newsletters (Fee-based)
Association of Clinical Research Newsletters (Free)
Professionals ACRP)
Barnett International Books, Reference Manuals
EducationalServices/Publications.aspx & Compendiums
Bureau of National Affairs Books, Directories &
(BNA) epages /bnastore.sf/ Handbooks
Canon Communications Newsletters (Free)
Canon Communications Newsletters (Free & Fee-
Pharmaceutical Media Group based)
CRC Online Press Books & Journals
Donawa Consulting Newsletters (Free)
Drug Information Association Directories, Compilations,
(DIA) Journals & Newsletters
DRW Research & Information Newsletters (Free)
FDANews Books, White Papers &
Newsletters (Free & Fee-
F-D-C Reports Newsletters (Free & Fee-
FDC-Windhover Newsletters (Free)
Ferdic, Inc. Newsletters (Fee-based)
FierceMarkets Newsletters (Free)
Food and Drug Law Institute Books, Directories, White
(FDLI) Papers, CDs & Journals &
Newsletters (Free & Fee-
Global Regulatory Press Newsletters (Fee-based)
GMP Publications Books, Handbooks &
Government Printing Office Books, Handbooks,
(GPO) Manuals, Guides, Journals
& Newsletters (Fee-based)
Infinata Newsletter (Free)
Informa Healthcare Newsletters (Fee-based)
Institute for Electrical and Books, Standards,
Electronics Engineers (IEEE) Conference Proceedings &
International Organization for Standards, Handbooks,
Standardization (ISO) CDs & Journals

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Publisher Website Resources

John Wiley & Sons Books & Journals
Lippincott Williams & Wilkins Books, Journals &
Newsletters (Fee-based) Books
Medical Device Manufacturers Newsletters (Fee-based)
Association (MDMA)
Medtech Insight Newsletters (Fee-based)
Parenteral Drug Association Books, Handbooks,
(PDA) Technical Bulletins, CDs &
Piribo Market Reports
Regulatory Affairs Professionals Books, Journals, CDs &
Society (RAPS) Newsletters (Fee-based)
SmartBrief Newsletters (Free)
Society of Clinical Research Journals
Associates (SoCRA)

SPG Media Newsletters (Free)

Springer Books, Handbooks &
Thompson Publishers Books, Reports, CDs &
library.jsp?cat=FOODDRUG Newsletters (Fee-based)
The Organisation for Newsletters (Fee-based)
Professionals in Regulatory
Affairs (TOPRA)
United States Pharmacopeia Books, Compendiums, &
(USP) Standards
VertMarkets Newsletters (Free)
VirSci Corporation Newsletters (Free)
Note: Website URLs are current at time of publication.

CRC Online Press, John Wiley & Sons, Lippincott Lippincott Williams & Wilkins, a division of Wolters
Williams & Wilkins/Wolter Kluwer Health, Kluwer Health, also produces several publications on
and Springer are major publishing firms that provide drug development, clinical trials and pharmaceuticals.
broad subject coverage while also featuring a signifi- Majors.coms publications focus on regulatory compli-
cant number of publications directed at the regulatory ance, quality assurance, risk management, HIPAA,
profession. coding and reimbursement, administrative law and
The CRC Online Press website contains numerous regulatory practice, pharmaceutical research, medical
regulatory books within the general category of phar- devices, biotechnology, chemistry, manufacturing and
maceutical science. Users can locate these publications controls compliance, laboratory auditing, validation and
within the following subcategories: biotechnology/biop- clinical research. Springer, by comparison, covers regula-
harmaceutical, cleaning and sterilization, clinical trials, tory and toxicology issues such as pharmaceutical safety
computer software, drug delivery and development, drug evaluation in its pharmaceutical science area.
discovery, laboratory, manufacturing and engineering, The following keywords are effective for searching
medical devices, quality assurance, regulations and stan- these online catalogs:
dards, training and validation. Similarly, John Wiley & regulatory
Sons produces regulatory publications on drug submis- regulatory affairs
sions, clinical trials, drug safety evaluation, pharmaceu- regulatory healthcare
tical manufacturing regulations, quality and preclinical pharmaceutical
development. biotechnology

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medical device quality management

pharmacology regulatory

Other industry publishers concentrate on specific Several industry publishers specialize in publications
regulatory areas such as quality assurance and standards. that focus entirely or largely on regulatory and compli-
For example, the American Society for Quality (ASQ ance issues. Barnett International is one such company; it
Press) publishes books, standards and training materials publishes regularly updated reference manuals, industry
relating to quality issues, and the Bureau of National compendiums and job aids to assist regulatory profes-
Affairs (BNA) concentrates on the legal aspects of regula- sionals in complying with federal regulations. It also
tory affairs. Selected topics covered by BNA publications prepares regulatory industry executive analyses, question
include pharmaceutical, biotechnology and health law, and answer guides on regulatory topics and a study site
intellectual property and patent law. training series for regulatory professionals. FDANews is
In the same manner, the United States Pharmacopeia another publisher that prepares reference tools specifi-
(USP), an official public standards-setting authority for cally aimed at the pharmaceutical, biologic and medical
prescription, over-the-counter medicines and US manu- device regulatory industry. Its products include the
factured healthcare products, develops documentary and CFR compilations, an adverse event compliance series
quality reference standards. Its key publications include and publications dealing with biologics, biosimilars and
the US PharmacopeiaNational Formulary (USPNF), combination drug products. Similarly, GMP Publications
the Food Chemical Codex and the USP Reference targets the regulatory industry through its CFR pocket
Standards. USP Reference Standards are based directly guides and good clinical practice and good manufac-
on official monographs in the USPNF, whose stan- turing practice handbooks.
dards and procedures are enforceable by the US Food The Government Printing Office (GPO), serves as the
and Drug Administration (FDA). The USPNF contains countrys official online bookstore for US government
public pharmacopeial standards for medicines, dosage publications. GPO serves as the primary resource for
forms, drug substances, excipients, medical devices and gathering, cataloging, producing, providing, authenti-
dietary supplements. USP Reference Standards are used cating and preserving published information in all its
to conduct identification tests, limit tests, drug substance forms for the executive, legislative and judicial branches
assays, system suitability tests and calibrations.1 of the federal government.2 Publications pertaining to
Another valuable standards resource for regulatory regulatory healthcare topics may be accessed by searching
professionals is IEEE, formerly the Institute of Electrical with the keywords FDA or the Food and Drug
and Electronics Engineers, which develops and publishes Administration and DHHS or Department of Health
conference proceedings, training materials, standards & Human Services combined with more specific terms
and publications central to regulatory research. It is the such as pharmaceutical, clinical or drug industry.
leading global professional association for the advance- GPO Access operates within the GPO to provide free
ment of technology and the authority on biomedical electronic access to legislative resources including
engineering and medical devices. Congressional bills, the Congressional Record, public
The International Organization for Standardization and private law, the US Code; executive sources such as
(ISO), similarly, is a key nongovernmental standards-pro- the CFR, the FR and presidential materials; and judicial
ducing organization, consisting of a network of national sources including the Supreme Court, trial and appellate
standards institutes for 159 countries and a coordinating court cases, opinions, oral arguments and decisions.
Central Secretariat in Geneva, Switzerland. ISOs catalog Another type of publication of particular value to regu-
comprises more than 175,000 published international latory professionals is the market research report. Piribo,
standards. which brands itself as online business intelligence for the
The American Society of Testing and Materials BioPharma Industry,3 specializes in this type of resource.
(ASTM) is additional example of a standards organiza- The UK-based publisher prepares detailed and costly
tion that produces Special Technical Publications, com- global market research reports, handbooks, strategic
pilations, manuals, monographs, journals and handbooks analysis profiles and regulatory overviews. Report subject
on regulatory topics. categories range from biotechnology, drug delivery and
Standards publications focused on healthcare regula- medical devices to prescription drugs, regulatory policy,
tory issues may be located by searching with the following and pricing and reimbursement. Urch Publishing, like
terms: Piribo, is a publisher of market intelligence reports cov-
biological ering the global pharmaceutical and healthcare industry.
biotechnology Also UK-based, Urch covers topics including chemicals,
clinical drug discovery/R&D, generics, pharmaceutical industry
pharmaceutical trends, pricing and reimbursement, regulatory, sales, and
medical device marketing and therapeutics.
medical instrumentation Thompson Publishing, by comparison, dedicates an

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entire product line to food and drug regulatory materials. for the pharmaceutical industry. The QMN Weekly
Thompsons products are primarily subscription-based Bulletin covers current quality management news, regula-
and are available in print or electronically. These prod- tory developments and inspection trends. The summaries
ucts generally consist of two-volume manuals containing provided by these publications offer brief but valuable
regularly updated newsletters, an archive and special perspectives on current regulatory management issues for
reports in conjunction with access to additional online drugs, devices and quality. A link to the full-text article
resources. Topics covered include good clinical practice, is listed below each summary; some of the cited sources
FDA advertising and promotion, FDA enforcement and require subscriptions to fee-based publications. These
medical device regulation. Aspen Publishers, another links afford regulatory professionals an opportunity to
division of the aforementioned Wolters/Kluwer, also pub- obtain further information on a particular subject as well
lishes a complete line of food, drug and medical device as learn about new resources.
publications. It provides detailed coverage of the FDA SmartBrief, an independent e-newsletter publisher,
approval process and expert guidance on generic drugs. produces 20 industry-specific daily newsletters that are
The majority of Aspens manuals are loose-leaf formatted available free of charge by subscription. This company
and subscribers automatically receive documentation partners with trade associations and professional soci-
updates, supplements and/or new editions. eties to publish its newsletters. AdvaMed SmartBrief
Many associations, such as the Regulatory Affairs is issued in conjunction with the Advanced Medical
Professionals Society (RAPS) and the Food and Drug Law Technology Association (AdvaMed) and targets medical
Institute (FDLI), publish materials intended for regulatory device, diagnostic product and health information system
professionals that are available in their online bookstores. professionals. BIO SmartBrief, produced in cooperation
This book is a key example of one such product produced with the Biotechnology Industry Organization (BIO),
by RAPS. In addition, RAPS publishes regulatory affairs focuses on biotechnology industry professionals, and
certification (RAC) exam preparatory materials for the FDLI SmartBrief works with FDLI to reach food and
US, Canada, the European Union (EU) and the new drug industry professionals. The summaries in all three
General Scope exam, as well as a self-assessment exam publications are based on original information from
for each certification. Also included in RAPS bookstore news organizations and repackaged by SmartBrief s edi-
are third-party publications of interest to regulatory torial staff. Each newsletter typically covers top stories,
professionals. FDLI, similarly, markets publications the healthcare in transition, hot topics, business and market
organization has prepared as well as third-party products trends, science and health or science and health policy,
addressing regulatory topics. emerging technologies, and product-specific and asso-
ciation-specific news. Regulatory professionals can use
Free Industry Resources (Electronic these publications to track current regulatory develop-
Newsletters (e-Newsletters) ments in time-saving compilations and obtain valuable
In addition to books, reports and standards, a number competitive intelligence.
of industry resources are available to regulatory profes- In a similar manner, VertMarkets has established
sionals to monitor current events and advance their 68 online community marketplaces for eight industry
knowledge of healthcare product regulation. This section groups to connect buyers and suppliers. For each of its
reviews both free and fee-based sources. However, the online industry communities, VertMarkets produces free
free publications will be discussed in greater detail as biweekly email bulletins that provide not only product
there are several valuable free sources of which regula- offerings, but also industry updates and the latest news
tory professionals may be not be aware. The fee-based to its members. The newsletters directed to regulatory
resources, by comparison, tend to encompass the more professionals fall into the life sciences category and
widely recognized monthly journals and association pub- include the Bioresearch Online Newsletter, Drug Discovery
lications made available as a membership benefit. The Online Newsletter, Laboratory Network Community
sources reviewed in this section cover a range of drug, Newsletter, Medical Device Online Community Newsletter
device and biologic regulatory publications. Although not and Pharmaceutical Online Newsletter. Typical content
comprehensive, they may give regulatory professionals a includes top news stories, featured articles, featured
solid basis for further independent research. downloads and a product showcase.
Many publishers produce multiple newsletters aimed FierceMarkets is a digital media company that also
at different healthcare product sectors. For example, specializes in supporting business-to-business marketing
FDAnews publishes the following free e-newsletters: in the life sciences, healthcare, IT, telecom and finance
FDAnews Device Daily Bulletin, FDAnews Drug Daily industries through its e-newsletters, websites, webinars
Bulletin and The QMN Weekly Bulletin. FDAnews Device and live events. FiercePharma is a daily e-newsletter
Daily Bulletin monitors FDA regulatory, legislative and focused on pharmaceutical company news and market
business news developments as well as selected inter- development of FDA-approved products. Regulatory pro-
national news affecting the medical device industry. fessionals can stay informed and save time by reviewing
FDAnews Drug Daily Bulletin provides parallel coverage these types of industry-specific publications. Categories

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included in FiercePharma are pharmaceutical company complete version of the latest issue, however, is accessible
news and reports, FDA rulings, regulations, recalls and on the website.
warnings, drug launches and safety, pharmaceutical sales, Three additional pharmaceutical industry-oriented
and marketing news and activities of key industry profes- e-newsletters published by Canon Communications
sionals. FierceBiotech is another daily e-newsletter in the Pharmaceutical Media Group are PharmaLive,
FierceMarkets digital product family. It concentrates on Therapeutics Daily and Daily Advantage. The subscrip-
drug discovery and clinical trials news as well as the latest tions to all three are free of charge if users register with
biotechnology trends, breakthroughs and FDA approval the website. These newsletters are
updates. FierceBioResearcher reports on biotechnology another great source of industry intelligence, providing
research news, information and tools, with a special summaries of industry events and trends affecting phar-
focus on the science of drug discovery. FierceVaccines, maceutical and clinical professionals accompanied by
FierceHealthcare and FierceSarbox are the companys a link to the full text and related articles. Information
other three e-newsletters within the healthcare division. is categorized by business and therapeutic area, and
F-D-C Reports, an Elsevier subsidiary, is a newsletter the news and information focuses on clinical research,
publisher that has been serving the healthcare product product marketing and pharmaceutical business. The
industry since 1939. Although the majority of its pub- therapeutic product areas covered in Therapeutics Daily
lications are fee-based, it does offer a complimentary include cardiovascular, oncology, pain and inflammation,
subscription to a few of its weekly e-newsletters. The first central nervous system and infectious disease.
of these is Biopharma Today, formerly FDA Legislative Several regulatory consulting firms also produce free
Watch. This e-newsletter covers current FDA reform newsletters to support their clients and the professional
initiatives specifically pertaining to the biomedical regulatory community. DRW Research & Information
industry. The second is Medical Devices Today, which Services, LLC, an independent regulatory research con-
provides strategy, regulation, innovation and investment sulting firm, produces a free monthly e-newsletter, DRW
coverage from The Gray Sheet, Medtech Insight, IN VIVO, Monthly, which covers a broad range of global healthcare
Start-Up, The Silver Sheet and Strategic Transactions. The regulatory topics. Each month is dedicated to reviewing
articles cover drug and business development, finance, medical device, biologic or pharmaceutical global regu-
strategy, regulation and reimbursement. Summaries latory developments. Donawa Consulting, a regulatory
and reprints are excerpted from recognized publications consultant based in Italy, also produces a quarterly pub-
including FDC Reports The Pink Sheet,The Gold Sheet, lication. The Donawa Consulting Newsletter provides an
Pharmaceuticals Approval Monthly and PharmAsia News overview of international medical device, quality system
and Elsevier Business Intelligences Start-Up and The and clinical regulatory developments.
RPM Report. Clinical monitoring news is another area covered
A few other free electronic resources worth in a free weekly e-newsletter entitled BioPharm Insight
briefly mentioning are Pharma Marketing News, the Clinical Newsletter. Infinata, the publisher, is also the
Pharmaceutical Technology Newsletter and PharmaFocus. developer of BioPharm Insight, a commercial, fee-based
VirSci Corporations Pharma Marketing News is a database discussed later in this chapter. The newsletter
monthly newsletter for pharmaceutical and marketing covers the latest information on clinical enrollments, clin-
professionals designed to keep subscribers informed ical results, drug approvals, drug licensing and medical
about industry trends and innovations. It also offers a devices. An additional free electronic resource providing
professional network for career advancement. Frequently current news for the clinical research community is the
covered topics include physician marketing, sales and Association for Clinical Research Professionals (ACRP)
education, regulatory compliance, patient education, and biweekly e-newsletter, ACRP Wire.
direct-to-consumer advertising and marketing. The medical device industry also receives excellent
Pharma Technology Newsletter is produced by a web coverage through a number of free publications.
UK-based company, SPG Media. The newsletter is dedi- Medical Device & Diagnostic Industry (MD&DI) is one
cated to pharmaceutical professionals working with tech- of 11 magazines published by Canon Communications
nology. Subscribers have access to the latest developments that focus on the medical technology industry. MD&DI
in global industry projects, company profiles, industry is a monthly magazine written exclusively for original
events and a recruitment section that provides career equipment manufacturers of medical devices and in
information and the latest job vacancies. PharmaFocus is vitro diagnostic products. For more than 25 years, it
also published in the UK, but unlike Pharma Technology has supported the industrys efforts to comply with
Newsletter, its primary focus is on news affecting the regulations, keep up-to-date on current events, improve
pharmaceutical industry and the UKs National Health manufacturing and design processes and understand
Service. This publication is a bit more exclusive in that market demand. Medical Device Link is a Canon publi-
it is only sent free of charge to selected permanent cation available free of charge by becoming a member of
employees of companies that manufacture ethical and Once a member, the user can
OTC pharmaceuticals and biotechnology companies. The sign up for all of Canon Communications publications.

396 Regulatory Affairs Professionals Society

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Medical Device Link is a biweekly email newsletter that Informa Healthcare, which is one of the largest pub-
reports on top industry headlines and important FDA lishers of business information for the pharmaceutical,
announcements and features articles from several of the biotechnology, medical devices and diagnostics indus-
publishers medical device trade publications. tries. Its two key regulatory publications are Regulatory
Affairs Journal (RAJ) Pharma and Regulatory Affairs
Fee-Based Industry Resources Journal (RAJ) Devices. RAJ Pharma has served as a key
The list of fee-based regulatory publications is long source of global news, commentaries and analyses of
and varied, ranging from industry newsletters and regulation in the pharmaceutical and biotechnology
peer-reviewed journals to association magazines. Key industries since 1990. Pharmaceutical regulatory intel-
publishers in the regulatory sphere include Canon ligence on worldwide rules governing the development,
Communications, Dickinson, F-D-C Reports, PJB launch and postmarket surveillance of medicines and
Publishers and Thompson Publishing. combination products is provided. Areas of coverage
The previously mentioned Canon Communications include regulatory agencies and legislation, application
Pharmaceutical Media Group also publishes two fee- requirements and guidelines, R&D, patents and intel-
based magazines: Med Ad News and R&D Directions. Med lectual property, international harmonization, pediatric
Ad News is an established resource for competitive busi- legislation, pharmacovigilance, pharmacoeconomics and
ness intelligence and marketing strategies information. drug safety. Since 1995, RAJ Devices has also reported
R&D Directions provides extensive coverage of pharma- on current worldwide news and provided analyses of
ceutical product development and insight into successful worldwide medical device regulatory affairs. Some
R&D strategies. Canon also publishes special reports on unique areas of focus include trade and environmental
biotechnology, company analysis, drug delivery and issues, healthcare systems and their impact on regula-
development, healthcare sales and marketing, pipeline tion and marketing, vigilance, and approval require-
data, strategic issues and therapeutic areas. ments and guidelines. Informa Healthcare also produces
Dickinsons FDAReview is a monthly newsletter pub- a broad range of fee-based industry news sources (e.g.,
lished by Ferdic Inc. that provides in-depth analyses of Scrip World Pharmaceutical News), business and market
the medical device and drug industries as well as FDA research reports, R&D analytical tools and databases
inspection and enforcement activities including Freedom (e.g., Pharmaprojects and TrialTrove), contact directories
of Information Act (FOIA) daily logs and Warning Letter (e.g., Scrip Directory) and research journals (e.g., Clinical
summaries. FDAUpdate is a weekly fax document con- Research & Regulatory Affairs, Drug Development and
taining FR updates pertaining to FDA rules and regula- Industrial Pharmacy).
tions, newly released Warning Letters, weekly filed citizen Elsevier Business Intelligence distributes several
petitions, advisory committee proceedings and calendar, e-newsletters that monitor business information and
and late-breaking FDA and pharmaceutical product intelligence trends, technologies and companies in the
news. Free items also available on Dickinsons interactive medical device, diagnostics and biotech industry. The
website, FDAWebview, include FDA Warning Letters, FR companys fee-based newsletters include Medtech Insight,
notices and an FDA calendar. IN VIVO: The Business and Medicine Report, START-UP:
In addition to the free e-newsletters published by Emerging Medical Ventures and The RPM Report. Medtech
FDAnews, this company distributes 10 fee-based sub- Insight is particularly useful to regulatory professionals
scription newsletters. The publications are: Clinical Trials for its clinical and industry perspectives on products,
Advisor, Devices & Diagnostics Letter, Drug GMP Report, procedures and technologies shaping the global medical
Drug Industry Daily, Generic Line, International Medical technology market. IN VIVO provides in-depth analyses
Device Regulatory Monitor, International Pharmaceutical of marketing, R&D, regulatory and finance strategies in
Regulatory Monitor, The Food & Drug Letter, The GMP the biopharmaceutical, medical technology and diag-
Letter and Washington Drug Letter. As mentioned above, nostics industries. START-UP examines new product
F-D-C Reports publishes newsletters designed to clarify and leading-edge company and investment trends in the
developments affecting US healthcare product and ser- pharmaceutical, biotechnology, medical device and in
vices marketing and regulation for industry executives, vitro diagnostics industries. The RPM Report is a useful
policymakers and analysts. Newsletters published by business resource for the biopharmaceutical regulatory
F-D-C Reports include: The Pink Sheet/The Pink Sheet professional. Its primary focus is on FDA, the Centers for
DAILY, Pharmaceutical Approvals Monthly, The Gold Medicare and Medicaid Services (CMS) and public sector
Sheet and PharmAsia News in the pharmaceuticals and issues. Global Regulatory Press Journal of Medical Device
biotechnology category; The Silver Sheet and The Gray Regulation is yet another important resource for medical
Sheet in the medical devices and diagnostics category; device regulatory professionals. This is a quarterly pub-
The Tan Sheet and The Rose Sheet in the consumer prod- lication currently only available in electronic format.
ucts category; and, Health News Daily in the health policy Regulatory professionals can monitor global regulatory
and biomedical research category. developments through legislative changes summarized
Another well-recognized, fee-based publisher is in each issue and obtain guidance from review articles

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analyzing current medical device regulatory and compli- issue in one or two pages and can be used to support an
ance issues. industry response to a regulatory concern.
Within the biologics/biotechnology sphere, BIO
Fee-Based Association Resources supports professionals engaged in R&D of new health-
The majority of association publications are free with care technology, biotechnology and others through its
membership but require non-members to pay an annual advocacy, business development and communications
subscription fee. RAPS is one example of an association services. Its member-only publication, BIO News, is
that publishes a monthly magazine, Regulatory Focus, published six times a year and reports on organizational
that is only available to its members. This magazine activities, professional perspectives on industry issues and
focuses on current regulatory issues affecting the drug, member activities. The Society for Biomaterials is another
medical device and biological healthcare product sectors. biologics-focused organization that promotes progress
Another member-based resource that RAPS offers is a in biomedical materials R&D. The society also publishes
weekly email newsletter, RAPS Weekly Update. Similarly, member-only resources to foster an understanding of
The Organization for Professionals in Regulatory Affairs current industry and regulatory developments among
(TOPRA) publishes an international journal, Regulatory regulatory professionals. Members are afforded free
Rapporteur, for its members that provides current news access to its official news magazine, Biomaterials Forum,
and analyses on regulatory and legislative topics. In which is available by subscription to nonmembers as well.
addition, TOPRA issues a quarterly member newsletter, The forum reports on current biomaterials community
In Touch, which serves as an association news digest activities and includes book reviews, technical briefs
covering member and organizational activities. FDLI and professional services information. The Journal for
publishes a quarterly magazine, the Food and Drug Law Biomedical Materials Research is the official journal of
Journal, which is also available free to members and by the society and is a peer-reviewed publication provided
subscription to the public. The journal features articles free to members. It features clinical studies and research
on food, drug, cosmetic, medical device and healthcare reports on a range of topics including the preparation,
technology industry regulation and legislation, implica- performance and development of new biomaterials.
tions of proposed regulations , policy trends and analyses Applied Materials is published as Part B of the journal. It
of court decisions in food and drug law. Its member-only contains peer-reviewed articles on device development,
resource, Update, is issued bimonthly and contains the implant retrieval and analysis, manufacturing, regulation
latest association and industry news, viewpoints on of devices, liability and legal issues, standards, reviews
industry-specific trends, FDA agency developments and of devices and clinical applications. Nonmembers may
articles on various regulatory topics. subscribe directly by contacting John Wiley & Sons.
In a similar manner, the Drug Information Association In the medical device and technology field, AdvaMed
(DIA) publishes DIA Today, a member newsletter cov- is a lobbying/advocacy organization that supports the
ering current industry activities, as well as the Drug industrys goals of advancing global healthcare and
Information Journal, a monthly scholarly, international, increasing patient access to medical technology. AdvaMed
multidisciplinary, peer-reviewed publication. The also promotes policies that encourage high ethical stan-
Parenteral Drug Association (PDA) has a membership dards, rapid product approvals, appropriate reimburse-
publication entitled PDA Letter that is comparable to the ment and international market access. Its members-only
ones produced by the other organizations. It reports on publications include three alerts: the Member Advisory
science, technology, quality, regulatory affairs, association Program (MAP) Alerts to follow the latest payment policy
news and updates relevant to the PDA community. The changes; the Technology and Regulatory News Alert to stay
PDA Journal of Pharmaceutical Science and Technology informed about key FDA regulatory developments; and
is a bimonthly publication that contains peer-reviewed the International News Alert to monitor global medical
scientific and technical papers covering the pharmaceu- technology sales and operations developments. By com-
tical and biotech industries. The journal is distributed parison, the Medical Device Manufacturers Association
to the PDA membership as a member benefit and is (MDMA) represents the interests of smaller, innovative
also available by subscription. PDA Technical Reports medical technology companies through its advocacy
are global consensus documents addressing a range of and educational services. Its member-only publications
topics relating to pharmaceutical production, validation include the Weekly MDMA Update, the Monthly Member
and quality assurance. Expert task forces prepare the Services Newsletter and the MDMA Q Review. The latter is
reports, which are then reviewed by technical forums and a quarterly e-newsletter for the entrepreneurial medical
ultimately evaluated and approved by an advisory board device community that covers updates on legislative and
and the PDA board of directors. PDA Technical Bulletins regulatory developments, association news and members-
are short, scientific position papers responding to issues only programs and events.
raised during worldwide regulatory inspections. These Two key associations in the clinical research area are
board-reviewed and approved papers address a single the aforementioned ACRP and the Society of Clinical
Research Associates (SoCRA). In addition to its free

398 Regulatory Affairs Professionals Society

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biweekly e-newsletter, ACRP publishes a bimonthly coverage of FDA advisory committee activities through
journal, The Monitor, featuring peer-reviewed articles, its AdComm Bulletins, summaries of new pharmaceu-
association news and a guide to certification preparation tical legislation and summary bases of approvals (SBAs).
courses and exams available only to members. SoCRA, In addition, subscribers can choose to receive the IDRAC
like ACRP, is dedicated to the continuing education and Weekly Alert, covering current global regulatory develop-
development of its members and publishes the SoCRA ments, or customize an email alert with saved queries
Research Journal, a members-only quarterly publication structured to meet their own information preferences.
that contains scientific and professional articles, society Wolters Kluwers MediRegs is also a provider of health-
news and events, and professional opportunities and ser- care research products and software solutions for regula-
vices. Selected articles from past issues of the journal are tory professionals. Its healthcare compliance software and
available to the public on SoCRAs website. risk management solutions product, ComplyTrack Suite,
enables risk and compliance professionals to restruc-
ture their compliance programs and risk management
Online Commercial and initiatives to achieve greater efficiency. Revenue Cycle
Government Databases Solutions software targets coding and reimbursement
Commercial Databases healthcare professionals while the Life Science Regulatory
Regulatory Intelligence Solutions online portal supports regulatory compliance
A number of commercial, fee-based databases are professionals in the pharmaceutical, device and food
available to support the regulatory professionals legis- industries. US and European database resources include
lative tracking and regulatory analysis responsibilities. regulatory publications, policy manuals, guidance docu-
These tools are extremely valuable when used in conjunc- ments, commission reports and automatic updates from
tion with other sources of regulatory expertise, from net- domestic and international regulatory bodies.
working with colleagues to contacting consultants and/ MediRegs US-focused regulatory resources include
or directly communicating with government agency the Pharmaceutical Regulation Suite and the Device
authorities. Regulation Library. The Pharmaceutical Regulation Suite
Tarius Regulatory Database, a fee-based subscrip- provides access to enforcement materials, Establishment
tion database service owned by the Danish publishing Inspection Reports (EIRs), 483s and Warning Letters
company, The Schultz Group, is included among these dating back to the 1970s, SBAs dating back to 1964, US
database providers. The Tarius database enables regula- Code and public law legislation, the CFR, the FR back
tory and quality professionals to stay informed about the to 1991, FDA/NIH manuals and guidelines and FOIA
latest legislative developments worldwide and to interpret logs. The Device Regulation Library also affords regula-
regulations and guidelines applicable to global healthcare tory professionals access to enforcement materials and
products. Tarius offers two types of products: custom- EIRs, 483s and Warning Letters, as well as establishment
ized regulatory and quality databases and predefined base registration and product listings, premarket approval
modules on drugs and devices. The customized database (PMA) summaries back to 1945 and FDA product safety
solution prescreens data from multiple global government information.
and legislative websites according to searches defined by Founded in 1975, FOI Services, Inc., is an additional
a particular company or individual. The predefined drug source for FOIA documents. The FOI online library
and device modules, by comparison, contain continu- contains more than 150,000 FDA-related documents
ously updated reference documents compiled from US including new drug application and abbreviated new
and EU regulatory authorities and key international drug application approval letters, drug reviews, drug
regulatory bodies. As part of its database subscription and biologics SBAs, dissolution reviews, device and bio-
service, Tarius offers users a complimentary daily elec- logics premarket notifications 510(k)s, PMAs, device
tronic summary of published FR proposed rules, notices Summaries of Safety and Effectiveness, EIRs, 483s,
and regulations pertaining to CFR Titles 9, 21 and 40 company/FDA inspection correspondence, Warning
relevant to drugs, biologics and devices. Tarius also pro- Letters, advisory committee minutes, guidance manuals,
duces a weekly newsletter, Tarius Standard Solutions, internal FDA meetings, color and food additive peti-
which provides regulatory intelligence documents based tions and veterinary FOI summaries. FOIA documents
on user-tailored profiles. Other users may pay a nominal may also be identified using the online commercial
fee to subscribe. database, DIOGENESFDA Regulatory Information
Liquents IDRAC is another fee-based global regula- Online. Available through the database vendor, The
tory intelligence database of regulatory, legal and scien- DIALOG Corporation, this resource provides data from
tific information accessed by professionals who develop FDAs Enforcement Reports, 510(k)s, PMAs, medical
and register human drug and biologic products. As is true device reports (MDRs) and the new drug list. Clients
of Tarius, IDRAC frequently updates its documents and can request documents not already available in FOIs
provides expert analyses on key regulatory topics for more library. This fee-based FDA document service offers
than 60 countries. The database also provides excellent an excellent path for professionals seeking essential

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Table 36-2. Commercial and Government Databases

Databases Website Subject Coverage
Drug/Biotech & Device
BioPharm Insight Business & Regulatory
e-Knowledgebase Business & Regulatory
FOI Services Regulatory Intelligence
Regulatory Intelligence
MediRegs Regulatory Intelligence
Drug/Biotech Business
Business & Regulatory
Drug/Biotech Business
Drug/Biotech & Device
Regulatory Intelligence
Drug/Biotech Clinical
Trial Intelligence
Federal agency information portal for
small businesses
Drug/Biotech &
Code of Federal Regulations Device Regulatory &
Legislative Intelligence
Federal agency form
Forms Catalog
Drug/Biotech &
Federal Register (FR) Device Regulatory &
Legislative Intelligence
Drug/Biologics &
FDA Warning Letter Database Device Regulatory
Establishment Registration & CFApps/Login/Index.cfm?CFID=19739204&CFTOKEN Biologics/Biotech
Biological Product Deviation =4b5801a44b35d755-36EF1D27-1372-5AE1- Regulatory Intelligence
Reporting 6AA44EA2CBE290EA
FDA/CBER Vaccine Adverse
Event Reporting System
Regulatory Intelligence
FDA/CDER Adverse Event Drug/Biologics
Reporting System (AERS) Regulatory Intelligence
FDA/CDER Approved Drug
Products with Therapeutic Drug/Biologics
Equivalence Evaluations Regulatory Intelligence
(Orange Book) Database

competitive regulatory intelligence while wishing to be Commercial DatabasesBusiness Intelligence

discreet about their research. In addition to the regulatory intelligence tools avail-
able to support a regulatory professionals surveillance,

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Databases Website Subject Coverage

FDA/CDER Bioresearch
Monitoring Information
Regulatory Intelligence
System (BMIS)
FDA/CDER Clinical Drug Regulatory
Investigator Inspection List Intelligence
FDA/CDER Drug Firm Annual Drug/Biologics
Registration Status Database drls/default.cfm Regulatory Intelligence
FDA/CDER Drugs@FDA Drugs/Biologics
Database Regulatory Intelligence
FDA/CDER National Drug Drugs Regulatory
Code Directory Intelligence
FDA/CDRH Advisory Meeting Device Regulatory
Materials Archive cfAdvisory/search.cfm Intelligence
FDA/CDRH Clinical Device Regulatory
Laboratory Improvement
cfdocs/cfCLIA/clia.cfm Intelligence
Amendments (CLIA) Database
(Manufacturer and User Device Regulatory
Facility Device Experience) cfMAUDE/search.CFM Intelligence
FDA/CDRH Medical Device Device Regulatory
Reporting (MDR) Database cfmdr/search.CFM Intelligence
FDA/CDRH Premarket Device Regulatory
Approval (PMA) Database cfPMA/pma.cfm Intelligence
FDA/CVM Animal Drugs@ / Drug Regulatory
FDA Database animaldrugsatfda/ Intelligence
Drug/Biotech & Device Regulatory &
Legislative Intelligence
Drug/Biotech &
GPO Access Device Regulatory &
Legislative Intelligence
NIH Clinical Research
NLM - PubMed Biomedical research
Toxicological research
OMB Regulatory
Regulatory &
Deregulatory Actions
Federal agency published regulations &
public comments
Drug/Biotech &
Thomas Device Regulatory &
Legislative Intelligence
Federal agency
information portal
Note: Website URLs are current at time of publication.

analysis and strategic planning responsibilities, numerous Originally, these resources were only accessible to pro-
commercial business intelligence databases are now avail- fessional information searchers, but now the databases
able to increase understanding of industry competition. are specifically designed for users without prior search

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experience. It is currently possible to independently and links to related websites. Pharmaprojects enables
access these invaluable resources through company drug regulatory professionals to analyze competitor per-
database subscriptions. formance, review R&D pipeline data to assess trends and
Infinatas BioPharm Insight, briefly mentioned earlier evaluate potential business partnerships. Data sources
in the chapter, is a fee-based online database that pro- include the companies themselves, Pharmaprojects
vides global biotechnology and pharmaceutical industry sister publication, Scrip World Pharmaceutical News and
competitive intelligence. This resource covers the entire interviews with company personnel who attend global
drug product lifecycle from discovery and development conferences.
through the drug approval stages, as well as licensing Another Informa Healthcare product that contributes
deals, pharmaceutical sales/projections, management to the wealth of available pharmaceutical intelligence
contacts and medical devices. BioPharm Insight part- database resources is Pipeline. This database consists
ners with Pharmawire journalists, a part of the Financial of all the novel drugs and formulations developed since
Times Group, to report on key events including drug 1980. These drugs are tracked throughout their product
pipelines, patent expirations and litigation issues, lifecycle and are kept in the database even if they fail
licensing pipelines, and merger and acquisition pipelines. at any stage. What makes Pipeline unique is that it not
The BioPharm Insight database consists of Pharmawire only affords web-based access to an unlimited number of
Intelligence, the Clinical Trials Network, Drug Profiles, employees under one site license, but also includes free,
Drug Forecasts and Drug Licensing Deals. The BioPharm unlimited research support from expert analysts and free
Devices database, in turn, affords users detailed coverage training. Regulatory professionals can use this global
of the medical device pipeline. Each company profile con- drug resource to monitor competitors R&D programs,
tains a review about of the organization and its markets, discover new competitors, evaluate the competitive
product forecasts and launches, manufacturing facilities landscape for a specific drug, benchmark product per-
and key management contacts. Profiles of devices cur- formance and identify potential collaborators.
rently in distribution are also included in the database, Elseviers PharmaPendium database, by comparison,
as well as clinical trial and investigational device exemp- provides drug safety data on US approved drugs. This
tion daily updates. And lastly, BioPharm Outsource is a online resource affords researchers searchable access
database containing detailed profiles of contract service using the Medical Dictionary for Regulatory Activities
providers for the pharmaceutical and biotechnology (MedDRA) search terminology. It also incorporates
industry. animal and human study data from FDAs Adverse
Another pharmaceutical industry competitive intel- Events Reporting System (AERS); drug monographs
ligence resource is eKnowledgebase, an interactive online from Mosbys Drug Consult; Meylers Side Effect of Drugs;
pharmaceutical database. eKnowledgebase is produced by preclinical, clinical and postmarket data from FDA
Canon Communications Pharmaceutical Media Group, approval packages/SBAs; Registry for Toxic Effects of
the publisher of the publications MedAdNews, R&D Chemical Substances toxicity data; and metabolite data
Directions and Trend Reports. This fee-based database for approved drugs. Regulatory professionals can use this
provides extensive company coverage as well as pipe- database to obtain pharmacovigilance data to evaluate the
line information for each stage of a drugs development. full scope of projected risks early in the drug develop-
eKnowledgebase is updated daily and contains more than ment process.
26,000 compounds in development and drugs currently While the pharmaceutical intelligence databases dis-
on the market. A user can choose to subscribe to the cussed earlier focus on drug pipelines and R&D data, Life
entire eKnowledgebase database, or purchase either the Science Analytics MedTRACK concentrates on world-
Pipeline portion to search drugs in development or the wide private and public biomedical company intelligence
Brands portion to search drugs on the market. data. MedTRACKs key areas of focus are company pro-
Informa Healthcares Pharmaprojects database also files and financials, product data, R&D spending, patents,
serves as a valuable source of pharmaceutical intelligence. corporate deals, venture financing, industry statistics and
This tool tracks more than 36,500 drugs in active develop- epidemiology.
ment with a drug, company and therapy profile for each. Clinical trial surveillance information is also accessible
The drug profile contains product data including therapies through Citelines TrialTrove. This database contains a
and indications by phase, originator and licensees, chem- comprehensive repository of global ongoing clinical trials
ical data and structure, clinical trials, pharmacologies, information. Clinical and regulatory professionals have
country information, licensing opportunities and more. access to competitive trial information organized by 90
The company profile consists of addresses, subsidiaries, disease groups through analyst monitoring of more than
overview of operations, financial results, joint ventures 12,000 data sources. As is true of the Pipeline database
and agreements, a licensing contact and a direct link to product, TrialTrove offers users a research support service
the corporate website. The therapy profile is comprised of with direct access to Citeline analysts for no extra charge.
incidence, prevalence and market data, trends and forth-
coming events, pharmacological strategies in progress

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Government DatabasesLegislative Government DatabasesFederal

and Regulatory Tracking Agency Resources
An integral component of a regulatory professionals In addition to the legislative and regulatory tracking
work is to stay informed about the latest regulatory and databases discussed previously, many federal agencies have
legislative developments. The resources reviewed in this built their own specialized databases to monitor specific
section highlight noteworthy governmental and nongov- regulatory issues and provide public access to biomedical,
ernmental database tools to support these monitoring clinical and other useful government resources. This section
and surveillance responsibilities. GPO Access, discussed focuses primarily on the databases created within FDAs
at the beginning of this chapter, operates within the GPO centers. The Center for Drug Evaluation and Research
to provide electronic access to legislative reference tools. (CDER) and the Center for Devices and Radiological
The FR, published by the Office of the Federal Register, Health (CDRH) have developed the largest number of
National Archives and Records Administration, serves database systems, with some overlap between CDER and
as the official daily publication for rules, proposed rules, the Center for Biologics Evaluation and Research (CBER).
executive orders, presidential documents, and federal The Center for Veterinary Medicine (CVM) and the Center
agency and organization notices. The FR volume for 2009 for Food Safety and Applied Nutrition (CFSAN) have also
is Volume 74 and it may be searched separately or in con- developed some unique databases. Due to chapter length
junction with prior years dating back to 1994, Volume 59. constraints, however, this summary will review only
Users may also sign up for a free daily email containing selected center databases. A comprehensive list of all the
the FR table of contents. The CFR codifies the general and agencys databases and corresponding website addresses is
permanent rules published in the FR. The CFR is divided provided in Table 36-2.
into 50 titles representing broad areas subject to federal CDER and CBER share the responsibility of reviewing
regulation. Each CFR volume is updated once a year and postmarket safety reports submitted to the Adverse Event
issued quarterly. Titles are divided into chapters, usually Reporting System (AERS), a database containing voluntarily
bearing the issuing agencys name. Chapters, in turn, are submitted reports on approved drugs or therapeutic bio-
subdivided into parts covering specific regulatory areas logic products. CBERs other database systems include one
(e.g., 21 CFR 316.24 = Title 21Food and Drugs; Part for storing incoming Biological Product Deviation Reports
316Orphan Drugs; ChapterGranting orphan-drug and a Vaccine Adverse Event Reporting System (VAERS).
designation.) Some CFR records on GPO Access date back Like the AERS database, VAERS is based on a cooperative
to 1996; all titles are available from 1997 to the current year. agency program between CBER and the Centers for Disease
Documents are available as ASCII text and PDF files.4 In Control (CDC) to address vaccine safety.
addition to the FR and CFR, GPO Access contains links to Two of CDERs most heavily searched databases focus
numerous searchable databases including Congressional on drug product approvals: the Approved Drug Products
bills, the Congressional Record, the US Code, statutes at with Therapeutic Equivalence Evaluations (Orange Book)
large and public and private laws. database, which lists drugs approved on the basis of
Unveiled in 1995, the Library of Congress THOMAS safety and effectiveness; and the Drugs @FDA database, a
Database was created at the direction of the 104th Congress searchable/browsable catalog of brand-name and generic
to make federal legislation publicly available. THOMAS prescription and over-the-counter human drugs and bio-
offers a vast range of government resources including logical therapeutic products approved since 1939. Drug
databases to search bill resolutions, bill and amendment manufacturing firms are required to register their sites
summaries, bills across multiple Congresses, public laws with Drugs@FDA within five days of commercial distri-
searchable by number, House and Senate roll call votes, bution and re-register annually at the Drug Firm Annual
legislation by sponsor, Congressional activity databases, Registration Status database. The National Drug Code
the Congressional Record, days-in-session calendars, com- Directory is a database of marketed prescription drugs
mittee reports and treaties., an independent, listed by universal product identifiers. CDERs two clini-
nonpartisan, noncommercial and open-source website cally oriented databases are the Bioresearch Monitoring
launched in September 2004, provides access to some of Information System, which identifies personnel engaged
the same tools available on THOMAS and GPO Access. in Investigational New Drug (IND) studies; and the
This website is extremely useful if a regulatory profes- Clinical Investigator Inspection List, which contains data
sional needs to monitor the status of federal legislation relevant to IND studies gathered by clinical investigator
or Congressional events. Users can subscribe to RSS feeds inspections.
(commonly referred to as really simple syndication) CDRH has built and maintains more than 15 databases
throughout the site or use trackers to create customized to monitor medical device and radiological products.
feeds and receive email updates. RSS feeds are a family of Its 510(k)sPremarket Notifications (PMN) database,
Internet feed formats used to publish frequently updated which contains releasable 510(k)s, and its Premarket
workssuch as blog entries, news headlines, audio and Approval (PMA) database, which provides manufacturer
videoin a standardized format.5 premarket approval status, are critical to device regula-
tory professionals. CDRH has also developed two adverse

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event reporting systems similar to CDERs AERS database: business forms issued by federal agencies. Forms may
the MAUDE (Manufacturer and User Facility Device be searched by agency, agency list or form number, and
Experience) database and the Medical Device Reporting alphabetically listed by form name or keyword. A direct
(MDR) (formerly CDRHs Device Experience Network) link to forms published on specific agency websites is
database. MAUDE presents voluntarily submitted user also available if the form being searched is not available
facility, distributor and manufacturer medical device through the Forms Catalog. The Office of Management and
adverse event reports between 1991 and 1996; and Budget (OMB) and the General Services Administration
MDR data consist of reports on devices that may have (GSA), in turn, jointly produce This website
malfunctioned or caused a death or serious injury from contains a catalog searchable by government agency to
1992 through 1996. Other noteworthy CDRH databases locate all the regulatory reviews conducted by OMBs
include the Advisory Committee/Panel Meetings data- Office of Information and Regulatory Affairs (OIRA). It
base containing both information about upcoming meet- also has a catalog of the GSAs Regulatory Information
ings and historical information with links to summaries Service Centers (RISC) semiannually published Unified
and/or transcripts of recent past meetings; the Clinical Agenda of Federal Regulatory and Deregulatory Actions
Laboratory Improvement Amendments (CLIA) data- dating back to fall 1995. The Regulatory Plan is part of
base, which represents commercially marketed FDA and the fall edition of the Unified Agenda. The Regulatory
CDC categorized in vitro diagnostic test systems; and the Plan serves as a defining statement of the administrations
Establishment Registration database, which comprises regulatory and deregulatory policies and priorities, while
domestic establishments engaged in the manufacture, the Unified Agenda provides information about regula-
preparation, propagation, compounding, assembly or tions that the government is considering or reviewing.
processing of medical devices intended for human use RISC is responsible for gathering and publishing infor-
and commercial distribution. CVMs Animal Drugs@ mation on federal regulations through the semiannual
FDA is comparable to CDERs Drugs@FDA and CDRHs Unified Agenda of Federal Regulatory and Deregulatory
510(k) and PMA databases. This database allows users Actions and the annual Regulatory Plan, both required
to search for approved animal drug products, suitability by Executive Order 12866, Regulatory Planning and
petitions, sponsors, the Green Book, CFR, FR, patents and Review. The same executive order gives OIRA the
exclusivity. In addition, FDA maintains its own Warning mandate to review federal regulations and information
Letter database through its FOI office. The Warning Letter collections. OIRA also develops and oversees the imple-
collection covers documents issued from November 1996 mentation of government-wide policies on information
to the present. The database can be searched by company, technology, information quality, privacy and statistics.8
subject, issuing office or date. also provides links to several other gov-
In addition to the regulatory information avail- ernment resources that will be briefly mentioned in this
able through FDAs databases, regulatory professionals section. The first is, the governments official portal
requiring biomedical research can access PubMed, the to federal agency websites and information. This website
National Library of Medicines (NLM) biomedical data- is the product of an interagency initiative administered by
base, which includes more than 18 million citations from the GAOs Office of Citizen Services and Communications.
MEDLINE and other life science journals dating back It provides a centralized database to locate information on
to 1948.6 NLM also produces TOXNET, the toxicology US local, state and federal government agency websites.
data network, which consists of databases on toxicology, is another resource that is linkable from
hazardous chemicals, environmental health and toxic Reginfo.govs website. It is an extremely valuable tool to
releases. For molecular biology information, NLMs locate government agency regulations, rulemakings or
National Center for Biotechnology Information (NCBI) notices, and is also useful for finding, submitting and
offers a comprehensive resource. Established in 1988, obtaining public comments on proposed FR regulations.
NCBI has created numerous public databases covering In addition, a comment can be directly submitted through
genetic sequencing and molecular processes affecting the website by accessing documents that are still open for
human health and disease, as well as developed software public comment., the US governments offi-
tools for analyzing genome data. And lastly, the National cial website for small businesses, is the final website to be
Institute of Healths (NIH) site contains reviewed as a link from This resource provides
current information to identify federally and privately information on regulatory compliance and other informa-
supported clinical trials for a range of diseases and condi- tion for small business owners. Managed as a partnership
tions. The database includes 71,340 trials sponsored by by 22 government agencies, offers a wealth
NIH, other federal agencies and private industry con- of information on regulatory compliance, legal issues sur-
ducted in all 50 states and 165 countries.7 rounding running a business and registration, license and
A few additional recommended federal databases are permit requirements. For example, a pharmaceutical or
the Forms Catalog and Branded as the US biotech small business can click on the industry link and
governments official hub for federal forms, the Forms find a page dedicated to complying with laws and regula-
Catalog contains many, though not all, of the citizen and tions applicable to producers, distributors and marketers of

404 Regulatory Affairs Professionals Society

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human and veterinary drugs, medicines, biologics, medical A few other particularly helpful pages within the
devices and equipment and controlled substances. FDA website are the Information for FDA-Regulated
Industry within the Office of Compliance and FOIA.
The Information for FDA-Regulated Industry page
Government Resources Related to organizes industry information by clearly defined
Healthcare Product Regulation categories: industry information by subject, small
The previous section reviewed federal agency data- business, adverse event reporting, compliance and
bases useful for legislative tracking and healthcare enforcement, contact FDA, whats new, food industry
product approval review and reporting. This section fea- and meetings/workshops. The FOIA page contains
tures government agency websites that offer additional links to frequently asked questions, how to make an
healthcare product regulatory information. FOIA request, FOIA fees, online payments, an elec-
tronic reading room, Annual Reports, the Privacy Act,
US Government Agencies reference materials, contacts and links to other FOIA
In addition to FDAs wealth of databases, the agency, requester centers within the US Department of Health
to its credit, provides users with many handy naviga- and Human Services (DHHS).
tional tools to obtain information from its website. Upon DHHS is the US federal agency whose mission is to
launching the agencys homepage, users are introduced protect the health of all US citizens and provide essen-
to numerous ways to access information, from using the tial human services. The office of the secretary and
search box highlighted in blue at the top of the page to its subdivisions carry out DHHS initiatives while 11
browsing the AZ Index listed directly below. Moreover, operating agencies perform a broad range of tasks and
users can select one of the broad subject categories (food, services, from conducting research and ensuring food
drugs, medical devices, biologics/blood/vaccines, animal/ and drug safety to funding grants and programs and
veterinary, cosmetics, radiation-emitting products and managing health insurance. The specific operating agen-
combination products) listed on the left-hand side of the cies are: the Administration for Children and Families,
page to be directed to an agency center or office. Within the Administration on Aging, the Agency for Healthcare
each of these links, additional navigational tools are pro- Research and Quality (AHRQ), the Agency for Toxic
vided to locate information. CDERs homepage offers Substances and Disease Registry, the Center for Medicare
the latest news, featured links, quick links to frequently & Medicaid Services, CDC, FDA, the Health Resources
searched topics and seven browsable, tabbed categories at and Services Administration, the Indian Health Service,
the top. The CDER Site Info link can be used to browse NIH, and the Substance Abuse and Mental Health Services
an alphabetical topic index. CBER offers similar choices Administration. Due to chapter length limits, the DHHS
through its links to current news, key center categories, operating agencies other than FDA are not discussed in
hot topics, general CBER information, useful government detail. However, they are listed with their corresponding
sites, a search box and the CBER alphabetical topic index. website addresses in Table 36-3 for readers to review.
CDRH provides links to industry assistance topics, health An especially valuable feature of the DHHS website is
topics, information about the center, news and events, the ability to subscribe to multiple DHHS and partnering
device program areas, radiological health, key topics, a agency publications with a single email address. Once a
featured site, information resources and a search box as user selects the Email Updates envelope icon at the top of
well as an alphabetical CDRH topic index. CFSAN sup- the page and enters the appropriate email address, he or
plies links to its center overview and activities, FDA docu- she can check the boxes next to all preferred publications.
ments, instructions for interacting with the center, recent These preferences will then be forwarded to the appro-
news, program areas, national food safety programs, priate agencies within DHHS. The partnering agencies that
special interest areas, other sources of information, list publications are the National Institute of Allergy and
prior notice, food facility registration, CFSAN search/ Infectious Diseases, AHRQ, CDC, FDA,,
subject index, and food, nutrition and cosmetics ques- the Department of Defense Military Health System, the
tions and answers. CVM presents key topics related to Presidents Malaria Initiative and USAID Health.
the center, news and events, hot topics listed horizontally It is also worth mentioning a few other govern-
and vertically on the website, a veterinarian newsletter, a ment agency websites that are helpful to professionals
search box and an alphabetical topic index. The Office conducting healthcare product regulatory reviews and
of Combination Products (OCP), which is the last main designing strategic product development plans. The first
category listed on FDAs homepage, plays a role in all of is the US Environmental Protection Agency, which exam-
the centers in which combination products are reviewed. ines the potential environmental, chemical and medical
Its links are designed to assist users in defining their own waste regulatory concerns related to developing various
products. Consequently, the links include product juris- healthcare products. The second is the US Federal Trade
diction/assignment of combination products, requests for Commission (FTC), which addresses issues related to
comment, guidance documents and procedures, reports, enforcing appropriate business competition and moni-
workshops and presentations and whats new. toring anticompetitive practices. The FTCs Bureau of

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Table 36-3. Agencies Associated With Healthcare Product Regulation

Agency Website Subject Coverage
Poisoning, Packaging, Labeling,
Consumer Product Safety Commission
Prescription/OTC Drug Products

Environment & Public Health, Chemicals,

Environmental Protection Agency
Air Pollutants, Medical Waste
Business Competition & Consumer
Federal Trade Commission
Food, Drugs, Medical Devices, Biologics/
Blood & Vaccines, , Animal & Veterinary,
Food & Drug Administration (FDA)
Cosmetics, Radiation-Emitting Products,
Combination Products
FOIA Reading Room
Information for the FDA-
Regulated Industry

Public Health, Food & Drug

Department of Health & Human Safety, Grants & Funding,
Services (DHHS)
Research, Health Insurance
Administration for Children &
Administration on Aging
Agency for Healthcare Research &
Agency for Toxic Substances & Disease
Centers for Disease Control &
Centers for Medicare &
Medicaid Services
Health Resources & Services
Indian Health Service
National Institutes of Health
Substance Abuse & Mental
Health Services Administration
Global Harmonization Task Force
Medical Devices

Consumer Protection is specifically responsible for mission is to protect the public from unreasonable risks of
handling fraudulent and dishonest consumer protection injury or death from a broad range of consumer products.
activities, which encompass advertising and e-commerce For example, its poison prevention packaging standards
oversight. Advertising and consumer safety are also key and testing procedures, as well as its child-resistant and
priorities to healthcare product regulatory professionals. senior-friendly packaging guidelines, determine how
The US Consumer Product Safety Commission (CPSC) over-the-counter and prescription drugs and physician
is another agency that deeply impacts a regulatory profes- samples must be packaged. Although a regulatory pro-
sionals product development decisions. CPSCs primary fessionals decision making process is shaped by several

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Agency Website Subject Coverage

International Conference on
Harmonisation of Technical Drugs & Biologics
Requirements for Registration of
Pharmaceuticals for Human Use
World Health Organization (WHO) Public Health, Drugs & Biologics
WHO Biologicals Program
WHO Essential Medicines &
Pharmaceutical Policies
Note: Website URLs are current at time of publication.

other federal agency regulations and guidelines, this Policies Department, which is involved in developing,
chapter will not go into detail about these governmental implementing and monitoring national medicines poli-
bodies. However, an in-depth and instructive discussion cies and guidelines. Another WHO program in which the
on this subject appears in a 2007 Regulatory Affairs Focus US participates is the Biologicals Program. The goal of this
article by Novales-Li and Temple.9 program is to ensure that national regulatory authorities
implement effective systems to ensure the quality and
Global Organizations safety of blood products and in vitro diagnostic devices.
Although this chapter centers on US regulatory infor- Table 36-3 lists websites for these global organizations.
mation resources, a few global organizations are too impor-
tant to overlook given the critical role the US plays within Industry Associations
each of these groups. The International Conference on Print and electronic publications, online commercial
Harmonisation of Technical Requirements for Registration and government databases and other Internet-based
of Pharmaceuticals for Human Use (ICH) is one of these government agency resources unquestionably have an
global bodies. ICH brings together the regulatory bodies integral place in a regulatory professionals work. These
of Europe, the US and Japan and experts from the phar- resources enable him or her to monitor the latest news,
maceutical industry in the three regions to discuss scien- track the status and development of laws, regulations and
tific and technical aspects of product registration.10 The guidelines and engage in effective strategic product devel-
organizations safety, efficacy, quality and multidisciplinary opment. It is, however, industry associations that func-
guidelines are indispensable to pharmaceutical regulatory tion as indispensable educational resources for regulatory
professionals as they evaluate proposed products to ensure professionals themselves. The organizations mentioned
regulatory compliance. The Global Harmonization Task earlier in the chapter, including RAPS, DIA, TOPRA,
Force (GHTF) is another international organization in BIO, AdvaMed, FDLI and ACRP, offer a broad variety of
which US regulatory representatives actively participate. learning opportunities to their members. Regulatory pro-
GHTF is a partnership between national medical device fessionals can initiate or update their knowledge of the
regulatory authorities and the regulated industry and is regulatory healthcare industry and fulfill core competency
composed of five founding members: the EU, the US, requirements by participating in classroom and online
Canada, Australia and Japan. Established in 1992, the courses, self-paced home study, audio and web-based
organization aims to harmonize regulatory practices that training and certificate programs and attend workshops
will ensure the safety, effectiveness, performance and and conferences. In addition to offering formal learning
quality of medical devices, promote technological innova- options, associations enable professionals to engage in
tion and facilitate international trade.11 These harmonized networking and exchange information with their col-
practices are incorporated and disseminated through leagues through forums and online communities.
documents developed by five GHTF study groups. Medical
device regulatory professionals review these documents Web 2.0 Tools
as they evaluate device conformity assessment, quality The second generation of Internet-based services, com-
management systems and postmarket surveillance issues monly referred to as Web 2.0, has enabled Internet users
surrounding their device products. The World Health to participate in more dynamic and interactive informa-
Organization (WHO) is the final intergovernmental body tion sharing. To complement the networking benefits of
to be considered in this section. WHO provides leader- industry association memberships, regulatory profes-
ship on health matters, shapes the health research agenda, sionals can now connect with colleagues through blogs and
and sets norms and standards within the United Nations. social networking websites. The rapidly growing number
The US actively participates in WHO activities, particu- of blogs, or weblogs, which are regularly updated journal
larly within its Essential Medicines and Pharmaceutical entries designed to be read by a professional audience

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and representing the unique personality of the author the greatest benefit from the abundant resources avail-
or website,12 is remarkable. Some of the more popular able, thereby increasing their productivity, effectiveness
blogs worth reviewing within the regulatory healthcare and overall expertise.
sector are: FDA Law Blog (Hyman, Phelps & McNamara
PC); Biotech Blog; Eye on FDA (RX for Pharma Industry References
Communications and Planning); Medical Device and 1. About USP An Overview. US Pharmacopeia.
Diagnostic Industry (MDDI) blogs including Device Available at: Accessed 7
Talk, Biomaterials Talk and Transforming FDA; HTA April 2009.
Blog (Health Technology Assessment); and Pharmalive 2. About GPO Access. GPO Access. Available at: www.
Blogs including PharmaBlogReview, MedAdNewsInsider Accessed 7 April
and R&D Directions Insider. This list does not begin to 2009.
scratch the surface of what is truly available for this pro- 3. About Us. Piribo. Available at:
fession; however, it is a good starting point. Accessed 7 April 2009.
Social networking sites are another widely used Web 4. Code of Federal Regulations (CFR) Main Page.
2.0 Internet service. Regulatory professionals can par- GPO Access. Available at:
ticipate in sites such as LinkedIn and RegulatoryWorld. index.html. Accessed 7 April 2009.
com to establish a public professional profile, search for 5. RSS. Wikipedia. Available at: http://en.wikipedia.
jobs, interact with colleagues, search for other regula- org/wiki/RSS_(file_format). Accessed 7 April 2009.
tory professionals, review uploaded presentations and 6. PubMed. NCBI. Available at: www.ncbi.nlm.nih.
read member interviews. LinkedIn is an interconnected gov/pubmed/. Accessed 7 April 2009.
network of experienced professionals from around the 7, About Available at:
world, representing 170 industries and 200 countries.13 Accessed 7
Joining the network is free and simply requires the user April 2009.
to create a profile summarizing his or her professional 8. to Federal Regulatory
experience and accomplishments. The information a user Information. Available at: www.reginfo.
chooses to make publicly available can then be searched by gov/public/. Accessed 7 April 2009.
other professionals within the LinkedIn network to meet 9. Novales-Li P, Temple L. Non-FDA Agencies
and collaborate with other members. RegulatoryWorld. Involved in US Healthcare Regulation. Regulatory
com is another social networking website designed Affairs Focus. Vol 12. No 8, pp 8-15 (August 2007).
exclusively for regulatory professionals. Launched in 10. Welcome to the official website for ICH. ICH.
2007, is still in the early stages Available at: Accessed 7 April 2009.
of defining itself. Currently, the site has 4,047 members 11. About GHTF. Global Harmonization Task Force.
from 75 countries, with the majority from the US and Available from: Accessed 7
the UK. As is true of LinkedIn, April 2009.
membership and its user services are free of charge.14 12. Glossary. bytown Internet. Available at: www. Accessed 7 April
Summary 2009.
This chapter has reviewed a wide range of print and 13. About Us. LinkedIn. Available at http://press.
electronic information resources and selected social net- Accessed 7 April 2009.
working tools available to regulatory professionals. From 14. About Us. Available at: www.
this review, it is clear that the wealth of publications, data-
bases and government, association and industry web- =bf3df0c9ecfbc53d5996da4c30370849. Accessed 7
based tools, as well as social networking opportunities April 2009.
that have sprouted up in just the past few decades is truly
staggering. The new challenge for regulatory professionals
is to distill the essential knowledge they require from the
vast storehouse of information available to perform their
jobs as effectively as possible. This will call for carefully
managing electronic and print subscriptions, becoming
skilled in using relevant government and industry data-
bases, making use of association educational resources to
advance professional knowledge and, finally, using social
networking tools with discipline and discrimination. In
this way, regulatory professionals will be certain to reap

408 Regulatory Affairs Professionals Society

Regulatory Information Resources

Review Questions
1. What is the best source to track pharmaceutical
a. MediRegs
d. GPO Access
e. All of the above

2. True or false: USP is an official public standards-

setting authority for prescription and, over-the-
counter medicines and US manufactured healthcare

3. CDRHs medical device adverse event reports from

1992 through 1996 are stored in which database?
a. Adverse Event Reporting System (AERS)
b. Medical Device Reporting (MDR)

1. e
2. True
3. b

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