Impact Story

by Pill Pals Customer Service | Sep 11, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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. ...