Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents
Maryll Toufanian
Director, Office of Generic Drug Policy
U.S. FDA
David B. Abramowitz
Partner
Locke Lord LLP
Kurt Karst
Director
Hyman, Phelps & McNamara PC
Christopher Pruitt
Director, Division of Legal and Regulatory Support
Office of Generic Drug Policy
U.S. FDA
John Bennett
Partner
Allen & Overy LLP
- 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
- Teva’s Copaxone citizen’s petition
- 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