Drugs/Biologics

Ropes & Gray provides counsel, representation, and strategic advice to pharmaceutical and biotechnology companies subject to the Food, Drug, and Cosmetic Act and related law.  We advise established and development-stage companies on the requirements and strategies to pursue marketing authorizations, including NDAs and BLAs.  With more than 25 years of experience on Hatch-Waxman and Orphan Drug issues, we have an in-depth understanding of the competitive issues that affect the industry.  We are also recognized leaders in the field of pharmaceutical promotion and compliance and have represented major pharmaceutical and biotechnology companies in areas ranging from biologics regulation to lifecycle management to Rx/OTC switches.

FDA @ Ropes & Gray is designed to serve as your one-stop resource for up-to-date analysis related to FDA regulatory developments.  For more information about recent developments affecting the pharmaceutical and biotechnology industries, please click on the links located to the left.  We continually update the links with the most current resources available, and we encourage you to regularly consult these pages.

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