Product sponsors are seeing some early changes from the US Food and Drug Administration’s reorganized inspection operations, including the need to send FDA-483 responses to different offices, but also faster engagement by product centers after inspections.
US FDA’s Inspections Reorg: Changes In Form 483 Responses, Faster Engagement With Product Centers
The agency’s compliance directors also discussed expectations for greater inspection and review efficiencies as part of the 1 October reorganization during a recent FDLI conference.
