Using FDA’s Citizen Petition Process and Litigation to Achieve Market Success

March 11, 2015 10:15am

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