FDA Not Writing A “Breakthrough” Guidance – Yet
This article was originally published in Pharmaceutical Approvals Monthly
The agency needs more experience making the decisions before it lays out the evidence threshold for a breakthrough designation, CDER Director Janet Woodcock says.
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Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.
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.