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 […]
April 15, 2024

Drug Alerts and Statements

4/15/2024 FDA establishes CDER Center for Clinical Trial Innovation (C3TI) 3/25/2024 CDER Establishes New Quantitative Medicine Center of Excellence 3/15/2024 FDA Announces New Quality Oversight Webpage […]
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