The New Drug Approval Process: An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues

Differentiate between an NDA and an ANDA. Define 505(b)(2) Applications. Review patent and exclusivity provisions. Outline content and organization of an ANDA. Discuss patent provisions and market exclusivity for innovator and generic products.

Radhika Rajagopalan, Independent Consultant, EAS Consulting Group

This session was recorded as part of FDLI’s Virtual Introduction to Drug Law and Regulation Course in April 2020. 

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