The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]

Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal […]

Product: Drugs Recipient: www.bigpharmausa.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.bigpharmausa.com FROM: The United States Food and Drug […]

Product: Drugs Recipient: www.24hreup.biz Germany Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.24hreup.biz FROM: The United States Food and Drug Administration […]

Product: Drugs Recipient: www.buyprosoma.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.buyprosoma.com FROM: The United States Food and Drug […]

Product: Drugs Recipient: www.buycodeine.us United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States TO: www.buycodeine.us FROM: The United States Food and Drug […]

Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of […]

Docket Number: FDA-2017-D-3101 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Pharmaceutical Quality The Food and Drug Administration (FDA or Agency) […]

On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) […]