RACHAEL HUNT counsels clients regulated by the U.S. Food & Drug Administration (FDA). She assists clients with a wide range of pre- and post-market regulatory matters, including regulatory strategy, FDA regulatory due diligence, drafting and evaluating regulatory compliance policies and procedures, reviewing advertising and promotional materials, as well as responding to enforcement matters.
Prior to joining Sidley, Rachael’s experience included:
- Conducting FDA regulatory due diligence of transactions in the life sciences industry
- Assisting in the successful appeal of a Not Substantially Equivalent determination by FDA
- Advising clients on regulatory requirements for labeling and product packaging of medical devices, cosmetics, and OTC products
- Counseling clients on responding to FDA inspections, warning letters and import alerts
- Conducting internal investigations of medical device and pharmaceutical companies as well as pharmacies and pharmaceutical drug distributors
- Representing clients in administrative, civil and criminal investigations and proceedings conducted by the DOJ, DEA, and FDA under the False Claims Act and the Federal Food, Drug, and Cosmetic Act
Rachael had previously clerked for the Honorable Bernard G. Skomal, Magistrate Judge, U.S. District Court, S.D. of California.
Rachael maintains an active pro bono practice and has previously assisted clients with guardianship cases and immigration issues. Rachael received the La Mancha award for her work with an asylum matter through Casa Cornelia.