Recipient: Recipient Name Konrad Rejdak, M.D. Konrad Rejdak, MD, PhD Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8, 20-090 Lublin Poland Rejdakk@gmail.com Issuing Office: Center for Biologics Evaluation and Research (CBER) …
AUDIENCE: Patient, Health Care Professional, Pharmacy, Gastroenterology ISSUE: The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. Reports were received from clinical …
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 …
In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the third reauthorization of the Generic Drug User Fee Amendments (GDUFA). The current legislative authority for GDUFA III expires in September 2027. At …
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 Summary Company …
Summary Company Announcement Date: October 09, 2025 FDA Publish Date: October 09, 2025 Product Type: Animal & Veterinary Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Salmonella …
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 …
Image By: George Tidmarsh, M.D., Ph.D., Director, Center for Drug Evaluation and Research Like all drugs, sunscreens must meet rigorous standards for safety and efficacy. Because consumers rely on sunscreens as an essential part of cancer prevention and …
For Immediate Release: September 30, 2025 Today, the U.S. Food and Drug Administration conditionally approved Dectomax-CA1 (doramectin injection) injectable solution for the prevention and treatment of New World screwworm larval infestations, and …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-02 Product: Drugs Recipient: Recipient Name Ralph A. DeFronzo, M.D. Recipient Title Department of Medicine, Diabetes Division Ralph A. DeFronzo, M.D. 7703 Floyd Curl Drive …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-03 Product: Drugs Recipient: Pamela K. Den Besten, DDS, MS 521 Parnassus Avenue Room S612, Box 0422 San Francisco, CA 94022-0422 United States Issuing Office: Center for …
For Immediate Release: September 30, 2025 Statement From: Martin A Makary, M.D., M.P.H. Commissioner of Food and Drugs - Food and Drug Administration As part of the FDA’s broader strategy to combat the crisis of youth vaping, we are launching an initiative …
Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-09-03 Product: Drugs Recipient: Pamela K. Den Besten, DDS, MS/University of California, San Francisco 521 Parnassus Avenue Room S612, Box 0422 San Francisco, CA 94022-0422 …
Delivery Method: VIA EMAIL WITH READ RECEIPT: NO HARD COPY TO FOLLOW Product: Animal & Veterinary Drugs Recipient: Recipient Name James C. Ogle, Co-owner Recipient Title Julie D. Cook, Co-owner Ogle Cattle Company, Inc. 312 Cattle Pen Road Bowie, TX …
Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-114 Product: Drugs Recipient: Recipient Name Katharine S. Person Recipient Title President, CEO, and CFO Persōn & Covey, Inc. 616 Allen Avenue Glendale, CA 91021 United States Issuing …
[9-30-2025] The Food and Drug Administration is advising consumers not to purchase or use Me Vale Madre, a product promoted and sold for migraine and stress pain on various websites, including ebay.com, and possibly in some retail stores. FDA laboratory …
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 …
Recipient: Recipient Name Mr. Sandeep Kumar Recipient Title Vice President - Quality Natco Pharma Limited Pharma Division, Kothur Village Rangareddy 509228 Telangana India Issuing Office: Center for Drug Evaluation and Research (CDER) United States …
