FDA’s requirements for approval of new drugs, generic drugs, and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers of prescription […]

FDA has issued a final guidance, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for Industry,” which introduces a comprehensive and […]

[9/18/2023] Today, CDER, along with FDA’s Center for Biologics Evaluation and Research and the Oncology Center of Excellence, issued the draft guidance Demonstrating Substantial Evidence of Effectiveness […]

For Immediate Release: September 15, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

Submit Comments by 10/10/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Submit Comments by 10/10/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Submit Comments by 12/18/2023 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Docket Number: FDA-2011-D-0611 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance document provides answers […]

On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) […]