The Long And Short Of Accelerated Approval Accountability In US
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
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Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
Keeping Track: Rebyota, Rezlidhia Rev Up US FDA Approvals; New Sponsors Sought For Poziotinib, Brexafemme
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.