Requests for Reconsideration at Division Level under GDUFA
MAPP: Responsibilities for the Assessment of In-Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
Reformulation Drug Products That Contain Carbomers Manufactured with Benzene
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How to Make an FOIA (Freedom of Information Act) Request to FDA
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EU Advances AI Integration for Enhanced Medical Product Regulation Through Joint HMA-EMA Big Data Steering Group and Regulatory Initiatives
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The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic product information (ePI) for human medicines in the European Union (EU).
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Can the generics omit braille when it is part of RLD labeling? Read about the USFDA's stand.
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FDA and ASHP Shortage Parameters