Breakthrough Pace Shows No Signs Of Slowing
FDA started off 2016 with a spate of new breakthrough therapy designations, feeding the popular program – and fueling agency concerns about workforce strain.
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The latest drug development news and highlights from our US FDA Performance Tracker.
FDA’s refuse-to-file letter for Firdapse in two ultra-rare neuromuscular disorders does not make judgments about the drug’s safety or efficacy, says Catalyst.
Coming Up On US FDA’s User Fee Calendar: Zynteglo Approval Kicks Off Busy Season For Advanced Biologics, Pediatrics
At least 17 applications are pending with late August and September 2022 user fee goal dates, the Pink Sheet US FDA Performance Tracker shows.