Using FDA’s Citizen Petition Process and Litigation to Achieve Market Success
Chad A. Landmon
Partner
Axinn Veltrop & Harkrider LLP
- Overview of FDA’s Citizen Petition process
- Market exclusivities and other issues that can be addressed in a petition
- Maximizing your chance of success before FDA
- To sue or not to sue FDA
- Strategies for prevailing in Court against FDA
- Recent court decisions involving FDA issues