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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.
Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures.
No date has (Reuters) -The U.S. Food and Drug Administration has delayed its decision on Eli Lilly's experimental treatment for early Alzheimer's disease and will hold a meeting of outside experts ...
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in ...
The vote clears the way for a final FDA decision on the treatment, which initially had been expected earlier this year before the agency called for the meeting so its independent panel of e ...
FDA v. Wages and White Lion Investments, L.L.C. 23-1038: Whether the U.S. Court of Appeals for the 5th Circuit erred in setting aside FDA’s denial orders of respondents' applications for authorization to market new e-cigarette products as arbitrary and capricious. July 2, 2024: December 2, 2024 Feliciano v. Department of Transportation: 23-861
The Food and Drug Administration has finalized its decision to call an end to the drug shortage of Eli Lilly's blockbuster GLP-1 products, often referred to by their formula name, tirzepatide. Eli ...