FDA “Breakthrough” Designation Bill Revives Debate About Legislating Flexibility
This article was originally published in The Pink Sheet Daily
FDA appears to support the idea behind the bipartisan bill, which would allow the agency to meet with the sponsor early in the development process when a candidate shows substantial improvement over existing therapies and consider expedited trials going forward.
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A look at the genesis of the US expedited regulatory pathway for drugs and biologics, its benefits, and how the program is working today.
The number of requests to use investigational drugs outside of clinical trials has grown and FDA typically approves all requests, but advocates still insist the process is set up to fail patients.
A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.