US FDA

FDA is requiring new warnings about the risk of serious breathing difficulties that can lead to death in patients who use gabapentanoids with opioid pain medicines or other drugs that depress the central nervous system.

FDA issues draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.” The draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs.

FDA seeks input on development and evaluation of abuse-deterrent formulations of central nervous system stimulants

Baxter Oncology GmbH – 09/26/2025. Country: Germany. Record Type: 483

This page is the main website for information pertaining to OMUFA reauthorization activities, including high level meeting minutes with industry while negotiations are ongoing.

Why Not Natural, Houston, Texas, is voluntarily recalling its Why Not Natural Organic Moringa – Green Superfood because they may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened im

LANSING, Mich. – (BUSINESS WIRE) – Neogen Corporation (NASDAQ: NEOG) is voluntarily recalling all lots within expiry of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution, for use in dogs, cats, and horses, to the veterinarian level. Neogen distributes this product, which is manufactured by a th

InnoStar Bio-Tech Nantong Company, Ltd – 11/1/2024. Country: United States. Record Type: Response to Form 483

Commerce, CA – Koikoi Trading Inc. is recalling certain lots of FU ZHOU FISH BALL products in multiple pack sizes (200g, 400g, and 5LB) because the products may contain undeclared allergens: wheat and sesame. People who have an allergy or severe sensitivity to wheat and/or sesame run the risk of a s

January 26, 2026 — Gerber Products Company is initiating a voluntary recall of limited batches of Gerber® Arrowroot Biscuits out of an abundance of caution due to the potential presence of soft plastic and/or paper pieces that should not be consumed. The material comes from an arrowroot flour suppli

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