0 Items
+1.855.816.PALS (7257) info@pillpals.co

QM CoE Educational Resources

by | Sep 11, 2025 | News

Discover educational resources available under the QM CoE.FDA/C-Path Institute Model Informed Drug Development Web-Based Training The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence...

Impact Story

by | Sep 11, 2025 | News

CDER research is helping to inform how peptide and protein therapeutics that are not monoclonal antibodies should be regulated.Background and scientific challengeThe most common mechanism of drug-induced QT prolongation[1] and the associated rare, but potentially...

Impact Story

by | 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 | 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 | 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...