Unapproved New Drugs/Misbranded
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Neogen Issues Voluntary Nationwide Recall of Neogen®Vet HYCOAT® Hyaluronate Sodium Sterile Solution
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 thAurobindo Pharma Ltd. Unit-XII – 09/5/2025
Aurobindo Pharma Ltd. Unit-XII – 09/5/2025. Country: India. Record Type: 483Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter
The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.Pediatric Exclusivity Granted
Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)HimGo may be harmful due to hidden drug ingredients
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.Real-World Evidence
Real-world data (RWD) and real-world evidence (RWE) played an increasing role in health care decisions. The 21st Century Cures Act, passed in 2016, placed additional focus on the use of these types of data to support regulatory decision making.
