Reuters reported on November 12, citing six sources familiar with the matter and internal documents, that the U.S. Food and Drug Administration (FDA) has put on hold a fast-track review initiative introduced by former Commissioner Robert M. Califf. The program, originally scheduled to launch in June 2025, aimed to reduce the review timeline for "priority" drugs to one to two months.
Of the 22 drugs granted priority vouchers, 12 have already been approved, with some receiving accelerated reviews by more than eight months. However, since Califf’s departure in May, no new drug has received a priority voucher, and the oversight executive committee responsible for the process has ceased operations. Sources said the FDA continues to accept applications but does not advance them after submission.
The U.S. Department of Health and Human Services stated that the pilot program remains active and is being refined based on feedback from public hearings. Nine drugs currently under consideration are now being reviewed by FDA career scientists.
Original article: toutiao.com/article/1881665281676297/
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