Jeffrey N Gibbs

Jeffrey Gibbs advises pharmaceutical, medical device, in vitro diagnostic, and pharmacy clients on a broad range of FDA regulatory matters. His practice includes regulatory strategy, product approvals, advertising and promotion, citizen petitions, enforcement actions, and compliance counseling. He regularly assists companies in navigating FDA requirements throughout the product lifecycle, from development and premarket review through post-market compliance.

Gibbs is particularly recognized for his work with medical device and diagnostics companies, providing guidance on product submissions, enforcement matters, inspections, and regulatory compliance. He advises organizations ranging from start-up companies to multinational manufacturers on complex FDA-related issues.

Jeffrey Gibbs joined Hyman, Phelps & McNamara in 1990 after serving at the U.S. Food and Drug Administration. Over more than three decades in private practice, he has developed extensive experience in FDA law and has advised clients on matters involving product approvals, marketing practices, enforcement actions, and regulatory compliance. He has been recognized for his work in the medical device sector and is frequently sought out for advice on FDA regulatory strategy.