Notes

This is just a screenshot of the Manufacturers page, taken in

November, 2008.
 Text Size Notes
U.S. Food & Drug Administration Search This is a rewrite of the Manufacturers page: http://www.fda.gov/cber/
manufacturer.htm.
FDA Homepage Food Drugs Medical Devices Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Combination Products
1
It uses the new page design, but the text has also been rewritten to be more web-
friendly. Specifically:
Biologics, Blood & Vaccines o The sentences are short and simple. They are in active voice. They can be skimmed
easily.
o Bullet lists create a more open page.
Biologics, Blood & Biologics, Blood & Vaccines o The most important information is presented first.
Vaccines o Hyperlinks are grouped.

Guidance, Guidance, Compliance & Regulatory Information Questions and Open Issues:
Compliance & The original page refers to both the “Manufacturers Assistance Branch” and the
The Manufacturers Assistance Branch can answer questions on many policy and Email Page “Manufacturers Assistance and Technical Training Branch”. I didn’t know which name
Regulatory procedural topics including:
Information was current, so I used the shorter of the two in this wireframe. Which is correct?
o Information on clinical investigators Print Page
o How to report an adverse event
1
Bookmark and share The page now has an announcement for a training program that closed on February 21. 2
Acts, Rules & o How to submit an application online (electronic submission)
I did not include this announcement in this wireframe.
Regulations o How to submit an Investigational New Drug Application (IND) to administer Get email updates
an investigational product to humans
Subscribe to RSS The phone numbers are the same general phone numbers shown in the Contact Us
Guidances Please contact us: module. Are there more specific numbers to use?
o Phone: 800-835-4709 or 301-827-1800 2
Establishment o E-mail: matt@cber.fda.gov Is the e-mail address an individual’s name or an acronym for the Manufacturers
Registration Assistance and Technical Training Branch? If the latter, I recommend putting it in in all
We answer questions and provide training to: CAPS, so it will look more like an acronym. This argues for using the longer branch name
o Large and small manufacturers (see paragraph 1), but which is correct?
Compliance Activities o Trade associations

Enforcement
Acts, Rules & Regulations Contact Us
Post-Market Activities Public Health Service Act 800-835-4709
301-827-1800
Rules
Imports & Exports
octma@cber.fda.gov
Comprehensive List of Laws Enforced
Code of Federal Regulations – Biologics Enforced
Center for Biologics
Evaluation and Research
1401 Rockville Pike, Suite
Guidances & SOPs 200N
Rockville, MD 20852-1448
Guidances by Topic & Year
Resources for You Manual of SOPs Media Inquiries

Consumers & Healthcare About CBER

Providers Imports & Exports
Compliance Program Guidance Manual – Imported CBER-Regulated
Industry
Products
Export Certificates

Importing Samples for Research Use Only

Other Topics
Compliance Activities
Enforcement

Post-Market Activities

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