GDUFA II: Inspection Information Takes Center Stage
This article was originally published in The Pink Sheet Daily
Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.
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Leveraging foreign surveillance inspections could help FDA ensure more sites are inspected more often.
US FDA's GDUFA II commitment to alert generics firms within 90 days regarding inspection results will put additional pressure on Form 483 responses, possibly starting later this year.
New ORA position intended to help get questions answered, but already being used to smooth inspection issues.