Internal FDA Guidance Further Constrains GDUFA III Get-Out-Of-OAI Card

15 Jun 2023

Generic drug firms won a narrow commitment from the US FDA to approve ANDAs without revisiting sites previously deemed deficient. But the agency's just-issued MAPP document implementing the commitment, which stems from pandemic-era travel frustrations, is narrower still. Recent reinspection results might explain why.

Monopoly get out of jail free card — more fine print on releasing andas from oai inspection results • Source: Shutterstock

The US Food and Drug Administration has established a set of policies and procedures it promised industry for approving generic drugs without manufacturing facility inspections despite quality concerns in certain constrained circumstances.

An internal guidance document the FDA posted 12 June fulfills a commitment the agency made as part of the third...