Delivery Method: VIA EMAIL WITH READ RECEIPT Product: Drugs Recipient: Recipient Name Mr. John Yi Recipient Title General Manager Janssen Vaccines Corp., A Johnson & Johnson Company 23, Harmony-ro 303beon-gil Yeonsu-gu Incheon 22014 South Korea Issuing …
Recipient: motionpharmacy.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States …
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./University of Texas …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use SILINTAN, a product promoted and sold for joint pain on various websites, including 123herbals.com, and possibly in some retail stores. FDA laboratory analysis …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Day Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Day Formula …
[9-23-2025] The Food and Drug Administration is advising consumers not to purchase or use Agebox iKids Growth Night Formula, a product promoted and sold to stimulate growth and promote health in children ages five and older. Agebox iKids Growth Night …
CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In FDA’s review of the effectiveness of the clozapine …
For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential …
FDA News Release Agency initiates safety label change and notifies physicians of possible link For Immediate Release: September 22, 2025 The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and …
Docket Number: FDA-2025-D-0918 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs …
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination …
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 20, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with Listeria …
FDA News Release New Treatment for Barth Syndrome Showcases FDA’s Commitment to Bringing Effective and Safe Medications to Patients in Need For Immediate Release: September 19, 2025 Today, the U.S. Food and Drug Administration granted accelerated approval …
On September 19, 2025, the Food and Drug Administration approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the …
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 Summary Company …
Date: October 9, 2025 Time: 8:30 a.m. - 6:00 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the …
[9-18-2025] The Food and Drug Administration is advising consumers not to purchase or use Primal Herbs Volume, a product promoted and sold for sexual enhancement on various websites, including primalherbs.com, and possibly in some retail stores. FDA …
Docket Number: FDA-2011-D-0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for …
Advancing Generic Drug Development: Translating Science to Approval Keynote Address Janet Woodcock, MD Acting Commissioner of Food and Drugs Food and Drug Administration COVID-19 Impact on Generic Drug Regulation and Evaluation Protecting Participants …
