Delivery Method: VIA Electronic Mail Return Receipt Requested Reference #: 320-25-78 Product: Drugs Recipient: Recipient Name Mr. Baohua Chen Recipient Title Chairman and President Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao Xin Street, Xunqiaozhen …
Delivery Method: Via Email Reference #: 320-25-79 Product: Drugs Recipient: Recipient Name Mr. Sean M. Kenny Recipient Title President Horizon Tool Inc. 7918 Industrial Village Road Greensboro, NC 27409 United States Issuing Office: Center for Drug …
Delivery Method: VIA Electronic Mail Reference #: 320-25-81 Product: Drugs Recipient: Recipient Name Mr. Anil Patel Recipient Title Owner and Director Kenil Healthcare Private Limited Plot No. 319, Village Acharasan, Ankhol-Vamaj Road Tal-Kadi, District …
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 Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded …
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 Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded …
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 RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to …
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 Administration RE: Notice of Unlawful Sale of Unapproved and …
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 made. The tables include legacy projects (those submitted prior to …
Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program Information COA Qualification Considerations and Requirements COA Development …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval. 2025 Biological License Application Approvals …
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as …
On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Full prescribing …
CDER would like to assist sponsors and applicants who have not previously submitted standardized study data and who are planning a submission to CDER. We offer a process to validate sample standardized study datasets. You must have an NDA, IND, BLA, ANDA, …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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