FDA Regulatory

Nixon Peabody’s FDA Regulatory team has the experience and knowledge to counsel national and international pharmaceutical, medical device, biotechnology, food, dietary supplement, and cosmetics companies as they navigate significant regulation and scrutiny Our services enable clients to comply with the complex structure of laws and regulations that impact every stage of product development and distribution, including laws and regulations enforced by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission, the Securities and Exchange Commission, the Patent and Trademark Office, the Drug Enforcement Agency, the U.S. Department of Agriculture, and each of their state equivalents.

Our practice is particularly adept at assisting Chinese and European Union companies with breaking into the U.S. market. Our knowledge of the issues unique to foreign pharmaceutical and medical product manufacturers, and the U.S. companies that deal with them, provides an edge to clients working in this unique space. We assist companies outside the U.S. with developing their FDA premarket strategy, and drafting the necessary submissions to the FDA. Further, we are familiar with the standards that Chinese companies must meet to satisfy FDA requirements, drawn from our experience with those regulations working at the FDA, as well as in our representation of companies before the agency.

Our full spectrum of services includes counsel on:

  • Regulatory compliance
  • Enforcement risk
  • Development and commercialization of products
  • Marketing and post-marketing issues
  • Off-label promotion
  • Development of regulatory compliance programs and training programs
  • Matters related to clinical research and human subject protection
  • The import/export of FDA-regulated products

Our FDA Regulatory clients include:

  • Pharmaceutical and medical device manufacturers and distributors
  • Biotechnology companies
  • Research institutions
  • Food producers, manufacturers, and distributors
  • Dietary and nutritional supplement manufacturers and distributors
  • Clinical laboratories
  • Cosmetics companies
  • Trade associations
  • Private equity funds investing in the life science industry
Boston • Chicago • Los Angeles • London • New York • Paris
Rochester • San Francisco • Shanghai • Silicon Valley • Washington • Albany
Buffalo • Long Island • Manchester • Palm Beach Gardens • Providence

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