Impact Story
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 of a compound based solely on its chemical...CMC and GMP Guidances
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.Alternative...Guidance for Industry
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 or Agency) is announcing the availability of a final guidance for industry...Nonprescription Drugs Advisory Committee Charter
COMMITTEE’S OFFICIAL DESIGNATIONNonprescription Drugs Advisory CommitteeAUTHORITYThe Nonprescription Drugs Advisory Committee (the Committee) is established under 15 U.S.C. §1451 et seq.; 21 U.S.C. § 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351,...Division of Applied Regulatory Science
Over-the-Counter Drug ResearchEvaluation of Sunscreen Active IngredientsDARS has conducted two randomized clinical trials which demonstrated systemic exposure of multiple commonly used sunscreen active ingredients under single and maximal use conditions. ...Gooder Foods Issues Allergy Alert On
Summary Company Announcement Date: September 10, 2025 FDA Publish Date: September 11, 2025 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk and cashews Company Name: Gooder Foods, Inc Brand Name: Product...Capturing Patient Experience Through Deep Learning
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 allows essential information to be communicated, retrieved, and analyzed. The development,...CDER Statistical Studies Innovate Measures of Adhesion
Drugs and the technologies used to deliver them evolve rapidly, and methods to evaluate them must be continually adapted to ensure the safety and efficacy of new medicines. An excellent illustration of this process of adaptation is recent work by Center for Drug...Click To Verify Security & Validation
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