{{Short description|In the US, due date for the FDA's response to new drug applications}} In United States pharmaceutical regulatory practice, the '''PDUFA date''' is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application.<ref name=":0">{{Cite web|last=Speights|first=Keith|date=2016-07-07|title=What Is a PDUFA Date?|url=https://www.fool.com/investing/stock-market/market-sectors/healthcare/pharmaceutical-stocks/pdufa-date/|access-date=2021-06-30|website=The Motley Fool|language=en}}</ref> It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and Drug Administration'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.<ref>{{Cite web|last=Office of the Commissioner|first=Center for Biologics Evaluation and Research|title=User Fee Performance Reports - FY 1995 PDUFA Performance Report|url=https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm117257.htm|access-date=2021-06-30|website=wayback.archive-it.org|language=en|archive-date=2017-04-06|archive-url=https://wayback.archive-it.org/7993/20170406002629/https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm117257.htm|url-status=bot: unknown}}</ref> The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals.<ref>{{Cite web|title=PDUFA|url=https://www.phrma.org/Advocacy/Research-Development/PDUFA|access-date=2021-06-30|website=www.phrma.org|language=en}}</ref> 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. {{As of|2021}}, this fee was {{US$|2875842}} for applications requiring clinical data and {{US$|1437921}} for applications that do not.<ref>{{Cite web|date=2020-08-03|title=Prescription Drug User Fee Rates for Fiscal Year 2021|url=https://www.federalregister.gov/documents/2020/08/03/2020-16833/prescription-drug-user-fee-rates-for-fiscal-year-2021|access-date=2021-06-30|website=Federal Register}}</ref> In return, the FDA strives to complete review of applications within 10 months for most applications and 6 months for priority reviews.<ref>{{Cite web|date=2020-04-09|title=GAO Analysis Says FDA is Meeting PDUFA Commitments|url=https://www.thefdalawblog.com/2020/04/gao-analysis-says-fda-is-meeting-pdufa-commitments/|access-date=2021-06-30|website=FDA Law Blog|language=en}}</ref> The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application 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 Food and Drug Administration in certain circumstances.<ref>{{Cite web|last=Center for Drug Evaluation and Research, Office of New Drugs |title=Manual of Policies and Procedures (MAPP) 6010.8 Rev. 1: NDAs and BLAs: Communication to Applicants of Planned Review Timelines |url=https://www.fda.gov/media/72710/download |archive-url=https://web.archive.org/web/20190910232506/https://www.fda.gov/media/72710/download |url-status=dead |archive-date=September 10, 2019 |access-date=2021-06-30 |website=FDA, Center for Drug Evaluation and Research |language=en}}</ref> 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.<ref>{{Cite web|title=When Does FDA Extend a PDUFA Date? {{!}} Eye on FDA|url=http://eyeonfda.com/2010/08/when-does-fda-extend-a-pdufa-date/|access-date=2021-06-30|website=eyeonfda.com}}</ref>
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.<ref>{{Cite web|last=Office of the Commissioner|date=2018-11-03|title=FDA Reauthorization Act of 2017 (FDARA)|url=https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/fda-reauthorization-act-2017-fdara|access-date=2021-06-30|website=FDA|language=en}}</ref> The reauthorization will expire in September 2027.<ref>{{Cite journal|last=Center for Drug Evaluation and Research|date=2021-06-10|title=PDUFA VII: Fiscal Years 2023 – 2027|url=https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027|archive-url=https://web.archive.org/web/20200605055020/https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027|url-status=dead|archive-date=June 5, 2020|journal=FDA|language=en}}</ref>
== Relevance == The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications,<ref name=":0" /> and while there is no official list of PDUFA dates,<ref>{{Cite web|title=What is PDUFA? {{!}} Eye on FDA|url=http://eyeonfda.com/2010/07/what-is-pdufa/|access-date=2021-06-30|website=eyeonfda.com}}</ref> several websites collect PDUFA dates from press announcements in a calendar form.<ref>{{Cite web|title=FDA Calendar – FDA Tracker|url=https://www.fdatracker.com/fda-calendar/|access-date=2021-06-30|language=en-US}}</ref>
== References == <references /> Category:Food and Drug Administration Category:Drug development Category:Regulation Category:Pharmaceutical regulation in the United States