In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

must respond to a

New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

or a

Biologics License Application A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into inters ...

. It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the

's drug approval activities in return for adhering to a largely fixed timetable of regulatory actions.

History

Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the

while ensuring a more predictable timetable for drug approvals. Under the PDUFA regime, New Drug Applications and Biologics License Applications (together referred to as 'human drug applications' in the PDUFA context) are levied a fee upon filing. , this fee was for applications requiring clinical data and for applications that do not. In return, the FDA strives to complete review of applications within 10 months for most applications and 6 months for priority reviews. The PDUFA date thus serves as a 'best estimate' of when a decision on a

or a

would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the

in certain circumstances. These include circumstances such as a 'major amendment', e.g. where data submitted to a final study report is updated or data inadvertently omitted is supplied. The PDUFA must be reauthorized every five years. The current version, PDUFA VII, was reauthorized as part of the Food and Drug Administration Reauthorization Act (FDARA) signed on 30 September 2022. The reauthorization will expire in September 2027.

Relevance

The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected.

Sponsors Sponsor or sponsorship may refer to a person or organization with some role (especially one of responsibility) regarding another person or organisation: *Sponsor (commercial), supporter of an event, activity, or person *Sponsor (legislative), a per ...

frequently publish PDUFA dates for their pending applications, and while there is no official list of PDUFA dates, several websites collect PDUFA dates from press announcements in a calendar form.{{Cite web, title=FDA Calendar – FDA Tracker, url=https://www.fdatracker.com/fda-calendar/, access-date=2021-06-30, language=en-US

References

Food and Drug Administration Drug development Regulation Pharmaceutical regulation in the United States