Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to […]

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by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This draft guidance document provides answers […]

[12/15/2023] Today, FDA is announcing final approval and implementation of required labeling updates to continue efforts to address the evolving opioid crisis, and to urge health […]

[03/13/2024] EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. For both NDA-approved and EUA-authorized uses, only NDA-labeled […]

[3-11-2024] Today, FDA issued a revised draft guidance, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry. Once finalized, the guidance will provide recommendations to help […]

[03/15/2024] Today, FDA is announcing a new webpage to showcase how the agency uses one of its oversight tools, inspections, to help ensure drug safety and […]

[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development […]

What is mifepristone and how does it work? Mifepristone is a drug that blocks a hormone called progesterone that is needed for a pregnancy to continue. […]

[10/17/2023] Today, CDER announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. CDER is gathering information […]