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What is the PDUFA date for drugs?

The PDUFA date is 10 months after the drug application has been accepted by the FDA or 6 months, if the drug is given a priority review designation.

What does PDUFA mean in pharma?

The Prescription Drug User Fee Act: Promoting the timely availability of safe and effective medicines to patients.

Is PDUFA same as FDA approval?

Once the FDA accepts a filing for the approval of a drug, the agency must complete its review process within 10 months in most cases. The date at the end of the review period is referred to as the PDUFA date. In some instances, the FDA grants Priority Review status to the regulatory filing for a drug.

What percentage of PDUFA are approved?

CharacteristicPercentage of drugs approved in 2023 Met PDUFA goal date* 89% First cycle of review 84% Approved in the United States before receiving approval in any other country 64% Priority review 56%5 more rows Jan 16, 2024

How long is PDUFA?

The PDUFA must be reauthorized by Congress every five years. The PDUFAs primary goal was to authorize the FDA to collect fees from drugmakers to help pay for the FDA staff needed to review regulatory filings for drugs.

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