Pharmaceuticals andBiotechnology Regulatory

Key contacts

Drug companies face pressure from many directions –a foreboding regulatory landscape, competitors withalternative brands or generics, and pushback frominsurers.

Philip Katz,

At the same time, they can find opportunities inmaximizing the benefits of statutes that encourage new
drug development. Whether you're a global
pharmaceuticals company or a biotechnology startup,
accomplishing business goals in such a highly regulatedindustry requires practical, integrated legal analysis andadvice.

Hein van den Bos,

We are creative in solving your problems thanks to ourbackground and experience. We not only know the law,
we know the nuances of the law because many of ourlawyers have worked in the U.S. Food and Drug
Administration. Others have worked in industry, whichmeans we also understand your business, the sciencebehind your business, and your marketplace. And toprovide integrated advice across jurisdictions, ourpharma/biotech lawyers in Europe, Asia, and Latin
America collaborate closely with our U.S. team, which isthe largest in the nation dedicated to providing
regulatory legal services to the industry.

Trending Topics

Our services are as varied as the challenges you face.
We offer timely, effective counsel on matters that include
product development, approval, post-approvalcompliance, and the development of next-generation

Washington, D.C.

Jane Summerfield,London
Amsterdam

Ernesto Algaba Reyes,
Mexico City

Lynn Mehler,
Washington, D.C.

Patent law in Europe

Areas of focus
Cell, Tissue, and Gene Therapies
Clinical Trials
Combination Products
Controlled Substances and DEA
Transaction and Securities
Disclosure Support and Due
Diligence
OTC Drugs and Cosmetics
Product Approvals and Disputeproducts. Our lawyers concentrate on particular areas ofthe law, such as advertising, manufacturing compliance,
regulatory exclusivities, and controlled substances. And
when your issues overlap with other disciplines, such as
intellectual property, litigation, or health carecompliance, we reach across the firm to tap into theneeded expertise, especially in our strong healthpractice.

Resolution
Regulatory Exclusivities, HatchWaxman, and Similar Statutes
Regulatory Inspections and cGMP
Hospitals and Health Care Providers
Licensing and Commercial
Transactions
Inflation Reduction Act

Representative experience
Instrumental in persuading FDA to change longstanding
regulatory position on awarding exclusively to fixeddose combination products, benefiting Gilead's
products in HIV and Hepatitis C fields.
Convinced FDA to give 5-year exclusivity to fixed dosecombination products that include a new chemical entityand a previously approved active ingredient.
Successfully sued FDA to overturn denial of orphan
drug exclusivity.
Help respond to FDA Form 483 observations, warning
letter to close out FDA investigation.
Negotiate settlement of FDA lawsuit alleging cGMP
noncompliance.
Conduct internal investigation of promotional practices
and help develop and implement enhanced practices.
Audit clinical trial study reports to ensure compliancewith adverse event reporting obligations.
Advise on FDA/DEA interplay during drug development
and approval process, scheduling under CSA.
Conduct due diligence of FDA and EU regulatory lawfor IPO.
Advising a research-based pharmaceutical company
with respect to a government demand for pricereductions under its federal contracts with the U.S.
DVA.
Advising private equity firm on FDA regulatory aspects

Related sectors
Life Sciences and Health Careof potential investments.

Awards and rankings
Band 1 for Healthcare: Pharmaceutical/Medical
Products Regulatory in the District of Columbia,
Chambers USA, 2020 - 2024
Band 1 for Life Sciences: Regulatory/Compliance,
Chamber USA, 2023-2024
Band 1 in Life Sciences, Chambers Global, 2020 2024
Tier 1 in Germany in Healthcare and Life Sciences:
Drug Advertising Law, Legal 500 EMEA, 2023
Tier 1 in Belgium in EU Regulatory: Pharma, Medical
Devices and Biotech, Legal 500 EMEA, 2023

Latest thinking and events
NewsSafe and correct use of food in interventional humanstudies
NewsFinal FDA electronic systems guidance offers greater
compliance flexibility
NewsCMS Issues Final Guidance on IRA 2027 Drug Price
Negotiation Program, 2026-27 MFP Effectuation
NewsCMS Issues Final Guidance on IRA 2027 Drug Price
Negotiation Program, 2026-27 MFP Effectuation
Hogan Lovells Events
CLENews
Rare pediatric disease Priority Review Voucher
program renewed through Dec. 20