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US FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals

 
• By Derrick Gingery

Agency will work past generic goal dates if approval can be achieved quickly thereafter, but now must create policy defining criteria for those situations.

Arrows miss target

The US FDA is attempting to define the circumstances when it may be acceptable to miss a generic drug assessment goal date, if it would mean a faster approval.

The agency agreed as part of the generic drug user fee program renewal that it would work past a goal date and not issue a complete response letter for an application if problems could be resolved and lead to "an imminent tentative approval that could prevent forfeiture of

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