US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows
Executive Summary
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.
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.
Firms That Get Complete Response Letters Might Get Inspected By US FDA Six Months After Replies
While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.
Keeping Track: Orladeyo, Danyelza, Imcivree Bring CDER 2020 Novel Approval Count Even With Full-Year 2019
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: