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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.
A 2002 U.S. Government Accountability Office (GAO) report found that PDUFA funds allowed the FDA to increase the number of new drug reviewers by 77 percent in the first eight years of the act, and the median approval time for non-priority new drugs dropped from 27 months to 14 months over the same period.
In 1915, the Public Welfare Board (PWB) was created and tasked with studying, coordinating and regulating all government and private entities engaged in social services. In 1921, the PWB was abolished and replaced by the Bureau of Public Welfare under the Department of Public Instruction.
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 ...
Amazing. Absolutely amazing. 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 ...
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 ...
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics ® and Triclonics ®), today announced that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act ...
The government of the Philippines (Filipino: Pamahalaan ng Pilipinas) has three interdependent branches: the legislative, executive, and judicial branches.The Philippines is governed as a unitary state under a presidential representative and democratic constitutional republic in which the president functions as both the head of state and the head of government of the country within a pluriform ...