This workshop provides an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Learn more.
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In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product quality and performance.
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Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients.
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Learn how to spot health fraud and avoid it.
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Bioresearch Monitoring Information System (BMIS) background page with download file.
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Educational Resources
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The Food and Drug Administration is advising consumers not to purchase or use X10 Natural Enhancement Supplement, a product promoted for sexual enhancement on various websites, including naturefuel.us, and possibly in some retail stores.
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Generic Drug Facilities, Sites and Organization Lists
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Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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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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Information on FDA-approved drugs released for sale on the market, such as dosage, side effects, and disposal methods
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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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