Expediting the Generic Drug Approval Process - Webinar Recording/Transcript
Expediting the Generic Drug Approval Process: FDA’s New Initiatives on Drug Competition
The FDA announced its Drug Competition Action Plan a year ago. And the agency continues to announce new guidances intended to speed up generic drug approvals. The FDA recently announced a guidance to enhance filing review requirements.
A record number of generic drugs have been approved this year. With the new expediting process, Commissioner Gottlieb believes that record highs will be achieved year on year.
Are you — and your new generic — ready for the expedited pathway?
In 90 fast-paced minutes attorneys Chad Landmon and Suchira Ghosh of Axinn, Veltrop & Harkrider LLP will methodically lay out the various policies, how they’ve been implemented, how you can engage with them and identify possible issues. You’ll learn the following:
- The new pathways to expedite approval of generic drug applications, including 180-day exclusivity
- Best practices to obtain exclusivity and the top don’ts for losing exclusivity
- Recent FDA policy statements and guidance on generic drugs and their impact on regulatory and quality professionals
- Substantive changes to REMS standards that impact ANDAs
- FDA’s other policy initiatives: prioritizing generic drug review; spur generic approvals to increase competition and lower cost, while maintaining quality
- How the real cost saving benefit provided by generics doesn’t come into full effect until there are multiple generic versions available
Order today to gain a clearer understanding of the various FDA initiatives surrounding generic drug access and how to best navigate these changes.