FDA Regulatory

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Advising many of the world’s leading pharmaceutical, biotechnology, medical device, food, cosmetic and other FDA-regulated life sciences companies, Ropes & Gray guides clients through the entire product life cycle.


Capital Insights

Visit our Capital Insights microsite, a hub for our latest legal thinking on the many regulatory changes emanating from Washington, D.C. when the new administration assumes leadership.

“Obviously very deeply knowledgeable about life sciences issues, in particular when there are regulatory matters that impact the deal.” Life Sciences Client, Chambers USA
“Robust practice sought after for a range of matters spanning healthcare, medical device and pharmaceutical issues. Offers substantial experience in regulatory issues including compliance and investigations work, coupled with pharmaceutical expertise encompassing advertising and patent advice.” Chambers D.C.
“They know the industry, they know the players, and they understand the interaction between manufacturing, IP and regulatory issues.” Client and Market Sources, Chambers USA


A clear understanding of FDA regulatory requirements is essential to the success of a life sciences company. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.

Our clients include many of the world’s leading pharmaceutical and biologics companies, medical device manufacturers and cosmetics, food and dietary supplement companies and distributors. We offer comprehensive services, including:

As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.

We also provide counseling to clients regarding other related government agencies, including the Federal Trade Commission (FTC), Consumer Product Safety Commission (CSPC) and the U.S. Department of Agriculture (USDA). Our advertising practice also includes representation of clients subject to challenges brought before the National Advertising Division of the Better Business Bureau (NAD). For more information about our services, please contact one of our FDA attorneys.

Industries Served

Our FDA attorneys have extensive knowledge and experience across various industries and segments within the life sciences industry. Our practice provides regulatory services for the following areas:


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