PADUFA

(redirected from Prescription Drug User Fee Act)
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AcronymDefinition
PADUFAPrescription Drug User Fee Act
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References in periodicals archive ?
The FDA has set an action date of February 4, 2020 under the Prescription Drug User Fee Act), and the agency has indicated that they are not currently planning an advisory committee meeting as part of the NDA review.
For the new drug application, the prescription drug user fee act (PDUFA) target action date is 15 August 2019.
Additionally, the Prescription Drug User Fee Act (PDUFA) date for completion of the review is 7 August 2018, concluded the company .
The original prescription drug user fee act (PDUFA) goal date had been 16 September 2010 but it had been postponed to 16 December.
Congress authorized the Prescription Drug User Fee Act (PDUFA) in 1992 as a vehicle for speeding up drug approvals and eliminating backlogs at the regulatory agency.
The Letter further stated that the FDA will continue to review the NDA for NKTR-181 according to the existing Prescription Drug User Fee Act timeline and will request additional information from Nektar, as needed.
In a letter dated December 19, 2018, the FDA had assigned a Prescription Drug User Fee Act, or PDUFA, target date for completion of its review by August 16.
Food and Drug Administration recently accepted for priority review a supplemental New Drug Application for Baxdela seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia; the FDA has assigned a Prescription Drug User Fee Act action date of October 24, 2019.
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