Information related to FDA’s preparation for the seventh reauthorization of PDUFA.
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The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
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These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
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Generic Drug Facilities, Sites and Organization Lists
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This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library - now hundreds of our recordings are readily accessible.
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FDA recognizes the increased use of AI throughout the drug development process and across a range of therapeutic areas. Learn more.
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CDER and CBER have collaborated with the European Medicines Agency (EMA) to develop 10 guiding principles that industry and product developers can consider when using artificial intelligence (AI) to advance drug and biological product development.
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Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.
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Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six
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FDA is establishing a STAR pilot program, which aims to shorten the time from the date of complete submission to the action date, in order to allow earlier patient access to therapies that address an unmet medical need.
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