US FDA Picks Up The Pace Of Complete Response Letters Over June And July
Executive Summary
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
You may also be interested in...
US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics
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
Keeping Track: Incomplete Responses For Unusual Times; Qtrypta Is Latest CRL
Highlights from complete response letter news from the Pink Sheet’s US FDA Performance Tracker.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: