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.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.