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.
- +$100 for nonmembers
Virtual Learning FAQ
On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.
On-demand content can be played back on most devices.
If you have concerns, please click the Test Your System link to determine your device’s compatibility, as well as system requirements.
CLE credit is not currently available for pre-recorded sessions.