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ANDA User Fee Misses Are Mostly Part Of 'Imminent Approval' Process

 
• By Derrick Gingery

US FDA will miss goal dates to reach speedier generic drug application approvals, but says decisions will be case by case.

Generics
The FDA may miss an ANDA goal date if it could mean a issuing a full approval instead of a complete response. • Source: Shutterstock

The FDA already has missed dozens of generic drug application assessment goals through its "imminent approval" process, but prefers to use its discretion to select the ANDAs rather than creating specific requirements for the applications that will affected by the process.

Imminent approval allows the FDA to intentionally miss an assessment goal if it could mean a faster full or tentative approval of the application. The idea is intended to help...

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