Prescription Drug User Fee Act (PDUFA) | PharmaBharat Tools

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Prescription Drug User Fee Act (PDUFA) | PharmaBharat Tools

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Advisory Committee(AdCom)Assessment Report Clock Start Clock Stop Complete Response Letter(CRL)Deficiency Letter Filing Review List of Outstanding Issues(LoOI)List of Questions(LoQ)Major Objection Prescription Drug User Fee Act(PDUFA)Refuse-to-File(RTF)Request for Information(RFI)Response Package Resubmission Review Cycle Standard Review

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RA User Fees, Timelines & ReviewPrescription Drug User Fee Act

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Major Objection Refuse-to-File (RTF)

Prescription Drug User Fee Act(PDUFA)

User Fees, Timelines & Review

Definition

A US user fee program under which sponsors pay fees to support FDA’s review capacity, in exchange for performance goals and target timelines for certain applications (e.g., NDAs/BLAs).

Regulatory source

PDUFA (as amended) and FDA performance goals