Learn more about FDA’s resources to provide manufacturers with information on the review and approval process for biosimilar and interchangeable products. Guidance for Industry FDA provides […]

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when […]

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) […]

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 […]