The Hatch-Waxman Landscape: ANDAs, and Exclusivities, American Conference Institute’s 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
Samantha G. Wilson of Young Conaway's Intellectual Property Litigation team will be speaking at the American Conference Institute’s 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA. The Passport to Proficiency program offers a comprehensive, three-week virtual series on Hatch-Waxman and BPCIA essentials for legal and business professionals in the biopharmaceutical field. Gain a foundation in regulatory components, IP subtleties, and patent life cycles to support business development.
Ms. Wilson will be co-presenting with Shannon K. Clark, Partner of Venable LLP, in the session entitled "The Hatch-Waxman Landscape: ANDAs, and Exclusivities." During this session, the co-presenters will discuss:
- Hatch-Waxman and reforms
- The NDA, 505(b)(2) and ANDA (Abbreviated New Drug Application) drug approval routes
- ANDA Standards for approval and the concepts of sameness and bioequivalence
- Local acting drugs, labeling carve outs and other nuances
- Market exclusivities and protection
- The different types of exclusivities
- NCE (new chemical entity)
To learn more about the American Conference Institute's Passport to Proficiency Program, visit Proficiency Series | American Conference Institute.
