On December 6, Axinn partner Chad Landmon and counsel Suchira Ghosh conducted a webinar entitled, "Expediting the Generic Drug Approval Process: FDA's New Initiatives on Drug Competition." In this 90-minute session, Chad and Suchira methodically laid out various FDA policies, how they have been implemented, how to engage with them and how to identify possible issues. Topics of discussion included:
- The new pathways to expedite approval of generic drug applications, including 180-day exclusivity
- Best practices to obtain exclusivity and the top dont's 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
Click here for additional information, including how to purchase a recording of the webinar.
Click here to view the presentation slides.