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