Assessment in Support of Sentinel System Public Report  FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion […]

CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products. In the case of a generic […]

Antimicrobial Regulatory Science Research Antimicrobial drug resistance is a major threat to public health. In March 2015, The National Action Plan for Combating Antibiotic-resistant Bacteria was […]

 Submit an annual report to FDA  Search the annual reporting database Annual Licensure Reporting Requirements Wholesale drug distributors and third-party logistics providers must be appropriately licensed […]

Quantitative structure-activity relationship (QSAR) models are becoming an increasingly important part of regulatory review because they can provide rapid assessment of the toxicological and pharmacological properties […]

COMMITTEE’S OFFICIAL DESIGNATION Nonprescription Drugs Advisory Committee AUTHORITY The Nonprescription Drugs Advisory Committee (the Committee) is established under 15 U.S.C. §1451 et seq.; 21 U.S.C. § […]

Docket Number: FDA-2023-D-3031 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

CDER researchers are developing methods based on deep learning, a kind of artificial intelligence (AI), to capture patient experience of medical products in a way that […]