Related Practices

Why Leading Companies Turn to Axinn for FDA Counseling and Litigation

Axinn’s FDA Practice Group provides counseling, advocacy, and litigation services relating to the development, marketing, and approval of FDA-regulated products, including new and generic drugs, biologics and biosimilars, medical devices, human tissue and stem cell products, and food and dietary supplements. Axinn frequently represents clients before the Food and Drug Administration and in federal court, often in matters of first impression. By coupling the firm’s knowledge of the complex and shifting regulatory landscape with the firm’s in-house scientific capability and patent, antitrust, and licensing expertise, Axinn offers a comprehensive team to enable companies to bring regulated products to market and defend their market positions in the most efficient, competitive and profitable manner.

Axinn’s FDA Practice Group has experience in the following areas:

In addition to representing clients before FDA, Axinn also litigates cases involving FDA law. In recent years, Axinn is one of the top firms to represent litigants in actions brought against FDA. 

Representative FDA litigation experience includes: 

 Representative FDA counseling experience includes:



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