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12:00 AM
 | 
Dec 08, 2003
 |  BioCentury  |  Regulation

PDUFA terminology

Time Stands Still

PDUFA terminology

Under the terms of the Prescription Drug User Fee Act, FDA seeks to complete standard reviews of drugs and biologics within 10 months of the submission of an application; the deadline for priority reviews is six months.

At or before the review deadline, the Center for Drug Evaluation and Research (CDER) issues a letter to the sponsor indicating which of three possible actions it is taking.

An APPROVAL letter allows the drug to be marketed in the U.S.

An APPROVABLE letter indicates that problems exist with the application...

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