An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Recorded November 9, 2022 | On-Demand Webinar
Understand the generic drug approval pathway and requirements of sameness, bioequivalence, and therapeutic equivalence. Recognize patent listing and certification requirements and implications for Hatch-Waxman patent infringement cases and generic drug approval. Learn eligibility requirements and scope of various market exclusivities for innovator and generic products.
This session was recorded as part of FDLI’s virtual Introduction to Drug Law and Regulation course in November 2022.