REGULATORY THINK TANK

Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation

September 22, 2022 8:15am

Kurt Karst

Kurt Karst
Director
Hyman, Phelps & McNamara PC

Brian Stone
Vice President
Assistant Global General Counsel Regulatory

Mylan

  • Reconciling Hatch-Waxman exclusivity with CGT exclusivity
  • Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence Hatch-Waxman litigation strategies
  • Exploring branded and generic interests in GDUFA and PDUFA renewals
  • Examining new attacks on 180-day exclusivity per the propose Blocking Act
  • Assessing status of FDA activity concerning Hatch-Waxman reform