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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.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.
The Prescription Drug and User Fee Act, commonly referred to as PDUFA, was set to expire in September, but rather than wait to the last minute, amidst the debt ceiling and practically every other ...
Under the Prescription Drug User Fee Act, the Food and Drug Administration has a limited timespan (known as the PDUFA date) to decide a New Drug Application, Abbreviated New Drug Application or Biologics License Application. The FDA may either approve the application or issue a Complete Response Letter. [2]
For years, branded-drug makers have paid for speed at the Food and Drug Administration. In 1992, the Prescription Drug User Fee Act, or PDUFA, established a fee for submitting marketing ...
The Prescription Drug User Fee Act, or PDUFA, was arguably lawmakers' greatest gift to drugmakers and their investors. Before PDUFA was enacted in 1992, reviews of marketing applications were long ...
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
I'm a little surprised that Exelixis' (NAS: EXEL) cancer drug cabozantinib hasn't gained Food and Drug Administration approval yet, which worries me a little. But just a little. Sure, the FDA set ...