Following are some illustrative examples of our experience:
- Helping companies coordinate with FDA during the entry process to avoid import refusals and address shipment holds.
- Advising companies on premarket authorization requirements for FDA-regulated products, including drugs, medical devices, and tobacco products.
- Helping companies respond to FDA Form 483s (inspectional observations) and Warning Letters.
- Bringing a successful challenge to FDA’s denial of a premarket tobacco product application. Wages & White Lion Investments, LLC v. FDA, 90 F.4th 357 (5th Cir. 2024) (en banc).
- 03.13.24 – Essential Legal Must-Knows for Thriving in the Life Sciences Sector – Part 3
An Ohio Life Sciences Event Presented by Thompson Hine
Select a filter
- The Basics of FDA Enforcement Actions,
International Association of Defense Counsel
, September 12, 2023 - Thompson Hine Expands Washington, D.C. Office with Addition of Former PBGC and FDA Lawyers,
Thompson Hine LLP
, August 8, 2023