PDUFA V ‘Program’ Gets Positive Evaluation – Except For Inspections
This article was originally published in The Pink Sheet Daily
Executive Summary
Longer application review time has been producing the improved communication sponsors expected, but modifications to the user fee program have yet to make inspections go smoother.
You may also be interested in...
US FDA's Inspection Decisions To Be Swayed By Facility "History" With Foreign Regulators
Leveraging foreign surveillance inspections could help FDA ensure more sites are inspected more often.
Sponsor-FDA Communications In IND Phase Will Get Outside Review
US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.
Inspection Delays Remain For Novel Approvals By US FDA; Will Quality Office Help?
Final assessment of the PDUFA V new drug review 'Program' flagged inspection delays as a continued sticking point for on-time approvals. US FDA says consolidation of manufacturing oversight under the agency’s new quality office will help.