Jul 3, 2025 · The date at the end of the review period is referred to as the PDUFA date. In some instances, the FDA grants Priority Review status to the regulatory filing for a drug.

Nov 4, 2025 · The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological …

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) to collect fees from drug manufacturers to …

Aug 7, 2025 · PDUFA stands for the Prescription Drug User Fee Act, first enacted by the U.S. Congress in 1992. Its primary purpose is to provide the Food and Drug Administration (FDA) with additional …

Mar 20, 2025 · The FDA is required to decide by the established PDUFA date, which can be either 6 or 10 months after submission. If the application is approved, this date becomes the official approval date.

PDUFA continues to play a critical role in strengthening the FDA’s ability to review human drug applications. The program also provides biopharmaceutical companies with greater regulatory …

Jul 30, 2025 · PDUFA VII assesses prescription drug program fees for certain prescription drug products. Program fees will be set to generate 80 percent of the total target revenue, amounting to …

2 days ago · Industry proposed several PDUFA funding formula changes intended to create more flexibility for the agency to add staff in the current hiring environment.

5 days ago · Ultragenyx resubmitted its Biologics License Application for UX111, a gene therapy for Sanfilippo syndrome type A, addressing previous manufacturing concerns and adding one year of …

The Prescription Drug User Fee Act (PDUFA) was first enacted in 1992 as a bipartisan solution to increase the efficiency of prescription drug review at the U.S. Food and Drug Administration (FDA).