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.
^Speights, Keith (2016-07-07). "What Is a PDUFA Date?". The Motley Fool. Retrieved 2021-06-30.
United States pharmaceutical regulatory practice, the PDUFAdate is the colloquial name for the date by which the Food and Drug Administration must respond...
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA)...
was granted 3.7 months ahead of the Prescription Drug User Fee Act (PDUFA) date. AbbVie Inc. manufactures Venclexta. It is marketed by both Abbvie and...
berotralstat for eligible patients in the United States. Berotralstat has a PDUFAdate for FDA approval on December 3, 2020. On December 3, 2020, the FDA approved...
the Food and Drug Administration has a limited timespan (known as the PDUFAdate) to decide a New Drug Application, Amended New Drug Application or Biologics...
2016). "FDA accepts AstraZeneca's brodalumab BLA for plaque psoriasis, PDUFAdate November 16". Seeking Alpha. Archived from the original on 8 February...
abaloparatide-SC was accepted in May 2016. A Prescription Drug User Fee Act (PDUFA) date was initially granted on 30 March 2016, but then extended to 30 June...
1860–8. doi:10.1378/chest.121.6.1860. PMID 12065350. "Encysive Announces PDUFADate for Thelin New Drug Application in Pulmonary Arterial Hypertension". July...
original on 2009-08-30. Retrieved 2009-10-20. "NeurogesX Announces New PDUFADate for Qutenza(TM) New Drug Application". Archived from the original on 2009-11-12...
bluebird's marketing application for ide-cel in and established a PDUFA goal date of March 27, 2021. US approval of ide-cel by March 31, 2021, is one...
Administration (FDA) in June 2018, with a Prescription Drug User Fee Act (PDUFA) goal date set for 23 March 2019. It was approved for use in the United States...
letter, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 21 July 2008. On 19 November 2008, an FDA antiinfective drug advisory...
review for tafasitamab, setting a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2020. On July 31, 2020, Monjuvi (tafasitamab-cxix) was...
Review, and established a target action date of September 8, 2015 under the Prescription Drug User Fee Act (PDUFA). The EMA validated the Marketing Authorization...
of the committee's recommendations were incorporated into drafts of the PDUFA IV amendment, which was signed into law as the Food and Drug Administration...
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