April 16, 2024

Data Standards Catalog

Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]
April 16, 2024

Guidance Snapshot Pilot

Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance […]
April 15, 2024

Drug Quality Sampling and Testing Programs

Hand Sanitizer NA LIQUID Cardinal Spirits Hand Sanitizer sampling and testing Assay, Impurities  Passed Assay; Failed Impurities  Hand Sanitizer Seatex Hand Sanitizer Alcohol Antisepetic 80% Topical […]
April 15, 2024

Completed PDUFA VII Deliverables

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 […]
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