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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. [11]
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 busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the ...
September proved to be a mixed month as far as drug approvals are concerned, with Mallinckrodt PLC (NYSE: MNK) and Aquestive Therapeutics Inc (NASDAQ: AQST) facing rejections.PDUFA dates are ...
The U.S. Food and Drug Administration's approval machinery churned out a lot of disappointments in November. Most of the negative verdicts were tied to difficulties the agency has had in ...
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.
Biotech stocks held steady in the recent week as earnings from the sector continue to trickle in. The week also saw presentations of clinical trial readouts at a couple of conferences. The ...
In November 2023, the FDA began its review and set the PDUFA date for September 2024. [ 14 ] The effectiveness of xanomeline/trospium chloride for the treatment of schizophrenia in adults was evaluated in two studies with identical designs. [ 2 ]