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The Future of Generic Drug Competition: Deconstructing FDA and Congressional Initiatives
Current and future measures by FDA and Congress to incentivize generic drug competition will have enormous impact on how quickly your drug gets to market.
What does this mean for 180-exclusivity? How can you obtain expedited approval and related marketing exclusivities?
Are you ready?
Get a handle on the new generic drug regulations landscape to your best advantage. This presentation is a must to gain insights into various ways to obtain expected approval and related marketing exclusivities.
Presentation Takeaways:
- The nuances of the implementation of FDA’s Drug Competition Action Plan (DCAP), including efforts to improve the efficiency of the generic drug development, review and approval process; maximizing scientific and regulatory clarity with respect to complex generic drugs; and closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended
- What the various pathways are to expedite approval of generic drug applications and the advantages and disadvantages of each method
- How to expeditiously obtain 180-day exclusivity
- How a sponsor can forfeit exclusivity
- How REMS standards are being used to reduce generic competition and what can be done to combat that effort
- How FDA’s citizen petition process is being used to reduce generic competition and what can be done to combat that effort
- What Congressional initiatives and measures are being proposed to spur generic drug competition
When you understand the new generic drug competition initiatives, you can successfully navigate the incentives that the FDA has put in place.