Nixon Peabody’s FDA Regulatory team has the experience and knowledge to counsel national and international pharmaceutical, medical device, and biotechnology 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 , 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 FDA practice is focused on:
- Product development, review, and approval
- Matters related to clinical research and human subject protection
- Regulatory compliance
- Enforcement risk
- Development and commercialization of products
- Market protection and exclusivity issues
- Marketing and post-marketing issues
- Off-label promotion
- Adverse events
- Response to 483s and warning letters
- cGMP requirements
- Development of regulatory compliance programs and training programs
- The import/export of FDA-regulated products
While our team can advise on the full range of pharmaceutical and medical device technologies, we offer particular experience with development of cutting-edge technologies such as stem cells, gene therapy, human tissue, xenotransplantation, pharmacogenomics, biomarkers, as well as drug/device combination products.
- FDA Cracking Down on Compounders at Historic Pace
Law360 | April 22, 2013
Washington, DC, health services and life sciences partner Areta Kupchyk provides commentary in this feature article discussing the U.S. Food and Drug Administration’s efforts to police the compounding pharmacy sector.
- Medical Apps Get the Once Over from the FDA
Marketplace | March 29, 2013
Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses mobile medical apps and the FDA’s guidelines for approval.
- FDA Seeks to Damp Criticism Over Mobile Health App Proposals
Reuters | March 21, 2013
Washington, DC, Health Services and Life Sciences partner Areta Kupchyk discusses the U.S. Food and Drug Administration’s plans for regulating certain health care apps used on smartphones and tablets.