1. Pink Sheet

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

 
• By Bowman Cox

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 five-year

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Complete Response Letters

More from Product Reviews