FDA GMP Dispute Resolution Guidance Allows 10 Days To Raise Objections
Executive Summary
FDA's dispute resolution draft guidance will allow manufacturers 10 days to challenge FDA inspection findings
You may also be interested in...
GMP Dispute Resolution Pilot To Cover Scientific And Technical Issues Only
An FDA dispute resolution pilot will cover scientific and technical Good Manufacturing Practice issues but not procedural or administrative matters
“Honest And Straightforward” 483 Responses May Avert Warning Letters
CDER is weighing companies' responses to FDA-483 inspection reports in considering whether to issue warning letters, Center for Drug Evaluation & Research Office of Compliance Director David Horowitz said
“Honest And Straightforward” 483 Responses May Avert Warning Letters
CDER is weighing companies' responses to FDA-483 inspection reports in considering whether to issue warning letters, Center for Drug Evaluation & Research Office of Compliance Director David Horowitz said