US FDA’s Non-Cancer Accelerated Approval Drugs Get Their Own Public Databases
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 New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
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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.
N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings
Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.
Accelerated Approval For Bluebird’s Skysona Gives Teeth To US FDA Data Questions
Two required confirmatory studies will bolster application that relied on historical controls for orphan neurodegenerative disease.