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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.
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 ...
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 ...
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 ...
In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will not be approved in its present form. [1]
Despite the FDA tied up with COVID-19-related activities, May turned out to be a positive month for biopharma companies from the perspective of drug approvals. Three new molecular entities were ...