PDUFA date
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.[1] 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.[2] 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.[3] 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$2,875,842 for applications requiring clinical data and US$1,437,921 for applications that do not.[4] In return, the FDA strives to complete review of applications within 10 months for most applications and 6 months for priority reviews.[5] 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.[6] 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.[7]
The PDUFA must be reauthorized every five years. The current version, PDUFA VI, was reauthorized as part of the signed on 18 August 2017.[8] The reauthorization will expire in September 2022.[9]
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,[1] and while there is no official list of PDUFA dates,[10] several websites collect PDUFA dates from press announcements in a calendar form.[11]
References[]
- ^ Jump up to: a b Speights, Keith (2016-07-07). "What Is a PDUFA Date?". The Motley Fool. Retrieved 2021-06-30.
- ^ Office of the Commissioner, Center for Biologics Evaluation and Research. "User Fee Performance Reports - FY 1995 PDUFA Performance Report". wayback.archive-it.org. Retrieved 2021-06-30.
- ^ "PDUFA". www.phrma.org. Retrieved 2021-06-30.
- ^ "Prescription Drug User Fee Rates for Fiscal Year 2021". Federal Register. 2020-08-03. Retrieved 2021-06-30.
- ^ "GAO Analysis Says FDA is Meeting PDUFA Commitments". FDA Law Blog. 2020-04-09. Retrieved 2021-06-30.
- ^ Center for Drug Evaluation and Research, Office of New Drugs. "Manual of Policies and Procedures (MAPP) 6010.8 Rev. 1: NDAs and BLAs: Communication to Applicants of Planned Review Timelines". FDA, Center for Drug Evaluation and Research. Retrieved 2021-06-30.
- ^ "When Does FDA Extend a PDUFA Date? | Eye on FDA". eyeonfda.com. Retrieved 2021-06-30.
- ^ Office of the Commissioner (2018-11-03). "FDA Reauthorization Act of 2017 (FDARA)". FDA. Retrieved 2021-06-30.
- ^ Center for Drug Evaluation and Research (2021-06-10). "PDUFA VII: Fiscal Years 2023 – 2027". FDA.
- ^ "What is PDUFA? | Eye on FDA". eyeonfda.com. Retrieved 2021-06-30.
- ^ "FDA Calendar – FDA Tracker". Retrieved 2021-06-30.
- Food and Drug Administration
- Pharmaceutical industry
- Regulation
- Pharmaceutical regulation in the United States