PHARMACEUTICALS & BIOLOGICS PRACTICE

ARENTFOX.COM

Pharmaceuticals & About Arent Fox LLP

Arent Fox LLP, founded in 1942,

Biologics Practice is internationally recognized

in core practice areas where
business and government

At a Glance intersect. With more than 400

lawyers, the firm provides
strategic legal counsel and
multidisciplinary solutions
to clients that range from
Fortune 500 corporations to
trade associations. The firm
has offices in Los Angeles,
New York, San Francisco, and
Washington, DC.

Related Practices

International Trade

Advertising, Promotions &

Data Security

Communications,
Technology & Mobile

Complex Litigation

Consumer Product Safety

Health Care

Intellectual Property

Related Industries

Guiding new drugs and biologics through a sea Medical Device

of regulations, Arent Fox is a leading authority on Life Sciences

pharmaceutical regulatory matters.

Arent Fox’s Food and Drug group maintains a very active pharmaceuticals and
biologics practice that offers a full range of regulatory and compliance services,
spanning issues associated with product development, commercialization,
and life cycle management. Our FDA and health care regulatory attorneys
work hand-in-hand to address the pharmaceutical regulatory and marketing
issues that frequently cut across those disciplines. We call on a deep
bench of professionals, including attorneys from the US Food and Drug
Administration and former in-house counsel, to develop practical, integrated
advice in bringing new products to market and keeping them there.

ARENT FOX LLP  LA / NY / SF / DC

 PHARMACEUTICALS & BIOLOGICS PRACTICE
ARENTFOX.COM

Key Contacts

James Ravitz
Partner, Practice Group Leader
james.ravitz@arentfox.com

Wayne Matelski
Partner
wayne.matelski@arentfox.com

Stephanie Trunk
Partner
stephanie.trunk@arentfox.com
Product Development
Brian Waldman
Our Food and Drug attorneys are experienced in shepherding drugs and biologics through the FDA
Partner
and, if relevant, the Drug Enforcement Agency (DEA) scheduling process, or, in the case of animal
brian.waldman@arentfox.com
health products, the US Department of Agriculture (USDA) or US Environmental Protection Agency
(EPA), when applicable. This work involves:
Naomi Halpern
Reviewing clinical research protocols and Assisting with clinical trial contracts and Counsel
related research and license agreements. reporting issues, including clinical trial audit naomi.halpern@arentfox.com
agreements.
Advising on, and filing, Investigational
Brian Malkin
New Drug Applications (INDs), New Drug Advising on FDA pre-market approval
Counsel
Applications (NDAs), 505(b)(2) NDAs , inspections.
brian.malkin@arentfox.com
New Animal Drug Applications (NADAs),
Performing domestic and foreign inspection
Abbreviated NDAs (ANDAs) and Abbreviated
audits. Emily Leongini
NADAS (ANADAs), Biologic Licensing
Associate
Applications (BLAs) for biologics, including Representing companies before the FDA
emily.leongini@arentfox.com
the new biosimilar 351(k) BLAs. to resolve outstanding issues and expedite
product approval.
Filing amendments or supplements to the
above applications. Preparing clients for FDA Advisory Committee
meetings.

Post-Market Regulatory

Our clients also turn to us for with a wide range of regulatory concerns that may arise once their
pharmaceutical products have been introduced to the market. This work includes:

Advising on adverse event reporting and Drafting and negotiating licensing,

Field Alert Reports, and coordinating product manufacturing, and distribution agreements.
recalls, including the development of crisis
Handling import and export issues.
management programs and plans.
Counseling on pharmaceutical and biologic
Helping clients understand regulatory issues
pricing and reimbursement issues, as well as
affecting the marketing and manufacturing of
government price reporting.
drug and biologic products.
Assisting with legislative and executive
Reviewing proposed advertising, labeling,
government relations at the federal and agency
and promotional materials, including web and
level to advance client interests.
social media sites.

Counseling clients on federal and state

traceability and licensing requirements
associated with drug distribution.

ARENT FOX LLP  LA / NY / SF / DC