Delivery Method: VIA Electronic Mail Reference #: 320-25-84 Product: Drugs Recipient: Recipient Name Ms. Lori A. Peterson Recipient Title Chief Information Officer Quality Assurance/Owner Nature’s Fusions LLC 57 North 1380 West Orem, UT 84057 United States …
[2-10-2025] The Food and Drug Administration is advising consumers not to purchase or use HimGo, a product promoted and sold for sexual enhancement on various websites, including ebay.com, and possibly in some retail stores. FDA laboratory analysis …
Search labeling on DailyMed NIH’s labeling tool designed to search over 140,000 labeling documents for prescription drugs, nonprescription drugs, animal drugs, and other products
For Immediate Release: July 21, 2025 The U.S. Food and Drug Administration today announced the appointment of George Francis Tidmarsh, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER). In this role, Dr. Tidmarsh will lead the …
For Immediate Release: July 18, 2025 The U.S. Food and Drug Administration today announced it has placed Sarepta Therapeutics investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold following three deaths …
GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Submit Comments by 10/21/2025 Although you can comment on any guidance at any time (see 21 …
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 …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. 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 …
Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-02 Product: Drugs Recipient: Mark J. Savant, M.D 2435 Ocean Avenue San Francisco, CA 94127 United States Issuing Office: Center for Drug Evaluation and Research (CDER) …
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 …
Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Harold I. Diamond Recipient Title President Diamond Chemical Co., Inc. Union Avenue & Dubois Street East Rutherford, NJ 07073 United States Issuing Office: Division of …
Submit Comments by 09/15/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …
FDA News Release Today’s action builds on Trump Administration’s deregulatory initiative. For Immediate Release: July 16, 2025 The U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding …
Docket Number: FDA-2024-D-5942 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance document provides you, blood establishments that collect blood and blood components, including Source Plasma, with FDA’s …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Tom Freyne Scope Health Inc 79 Madison Ave, Fl 8 New York, NY 10016 United States hello@optase.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Susan K. Benton Recipient Title President Thea Pharma, Inc. 303 Wyman Street, Suite 205 Waltham, MA 02451 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Kyle Guinness Revitalize Energy, Inc. 6401 Penn Ave. Suite 300 Pittsburgh, PA 15206 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Alvaro E. Arenas, AMBR EyeTech One, LLC 8833 Cypress Preserve PL Fort Meyers, FL 33912 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United …
Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Clint Worley, COO Covalent Medical 24600 Millstream Drive, Ste 410 Aldie, VA 20105 United States CWORLEY@focusvitamins.com Issuing Office: Center for Drug Evaluation and Research (CDER) …
