Docket Number: FDA-2015-D-3517 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

On This Page This FDA/PQRI Workshop will bring together experts from industry and senior leaders from CDER’s Office of Pharmaceutical Quality (OPQ) for interactive discussions on […]

Docket Number: FDA-2015-D-3539 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

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For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when […]

For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) […]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