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

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