US FDA Picks Up The Pace Of Complete Response Letters Over June And July
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
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FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.
Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.