Hilary Hoffman is an associate in the FDA Regulatory and Life Sciences Compliance group. She represents life sciences companies in connection with government enforcement actions, regulatory compliance, and internal investigations.
Hilary works with clients in a variety of life sciences industries, including pharmaceuticals, biologics, dietary supplements, and medical devices. She regularly counsels clients on issues such as good manufacturing practices, data integrity, and regulatory filings, and has assisted clients in drafting responses to FDA Form 483s and Warning Letters. She has also advised clinical laboratories, pharmacies, and healthcare group practices in False Claims Act qui tam litigation, Federal Anti-Kickback Statute investigations, and acquisitions.
Prior to joining Morrison & Foerster, Hilary was an associate in the Food, Drug, and Medical Device Compliance and Enforcement group of an AmLaw 100 firm, where she advised on enforcement actions taken by the FDA, internal investigations, mergers, and litigation. She played a major role in litigation supporting the rescission of a $4.75 billion acquisition over FDA compliance issues.
Hilary received her J.D. from New York University School of Law, where she served as an Executive Editor of the New York University Law Review. While in law school, Hilary was a judicial extern for Judge Edgardo Ramos in the Southern District of New York, as well as the Civil Division of the U.S. Attorney’s office in the Eastern District of New York. She also interned for the Partnership for Children’s Rights, where she advocated on behalf of parents and children to obtain appropriate special education services from the New York City Department of Education.Show More