Submit Comments by 04/07/2025 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-2024-D-3334 Issued by: Guidance Issuing Office Oncology Center of Excellence For drugs granted accelerated approval, sponsors have been required to conduct confirmatory studies postapproval […]

Submit Comments by 04/07/2025 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-2008-D-0053 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for […]

Submit Comments by 04/07/2025 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 […]

For Immediate Release: January 03, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

On This Page Date: March 27 – 28, 2025 Day1: Thu, Mar 27 9:00 a.m. – 04:00 p.m. ET Day2: Fri, Mar 28 9:00 a.m. – […]

December 4, 2024 NCTR Uncovers Drug Interaction with UGT Enzymes as an Indicator of Drug-Induced Liver Injury Researchers at FDA’s National Center for Toxicological Research (NCTR), […]

Docket Number: FDA-2024-D-5374 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine This guidance, […]