Hilary Hoffman is an associate in the FDA Regulatory Group. She represents life sciences companies on matters spanning the entire product development lifecycle, including clinical development programs, product classification analyses, marketing authorization submissions, and post-market compliance. She counsels clients in connection with acquisitions, regulatory compliance, government enforcement actions, private litigation, and internal investigations.
Hilary works with clients in a variety of life sciences industries, including pharmaceuticals, medical devices, in vitro diagnostics, laboratory developed tests, biologics, and dietary supplements. She regularly counsels clients on topics such as good manufacturing practices, data integrity, clinical trial requirements, advertising and promotion, post-marketing obligations, and regulatory filings. Hilary also assists clients in preparing for regulatory inspections and drafting responses to FDA Form 483s and Warning Letters. She also has advised clinical laboratories, pharmacies, and healthcare group practices in False Claims Act qui tam litigation and Federal Anti-Kickback Statute investigations.
