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Exclusive: US FDA to fast-track nicotine pouch reviews amid White House pressure

The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms' nicotine pouches in a pilot program launching on Monday, amid pressure from the Trump administration to speed up approvals,
CSP Daily News4h

FDA plans program to fast-track nicotine pouch authorizations

New tobacco products must submit a premarket tobacco product application (PMTA) and receive authorization, or a marketing granted order (MGO), from the FDA in order to be legally sold in the United States. In January, the FDA issued MGOs to 20 Zyn nicotine pouch products. PMI bought Zyn maker Swedish Match North America in 2022.
Devdiscourse1h

Fast-Track FDA Plan Puts Spotlight on Nicotine Pouches

The FDA initiates a fast-track program for reviewing nicotine pouches from major tobacco firms, under pressure from the Trump administration. The program aims for quicker legalization and market entry,

US FDA tightens control over obesity drug ingredient imports amid safety concerns

The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk.
Hoodline4d

FDA Issues Alert for H5N1 Contamination in RAWR Raw Cat Food, Company Disputes Handling of Information

The FDA has notified of H5N1 contamination in RAWR Raw Cat Food, linking it to a deceased cat. RAWR disputes the FDA's handling and has recalled affected lots, advising customers to cook the food to 165°F or opt for refunds/exchanges.
MPR1h

FDA Denies Approval of Dichloroacetate for Rare Mitochondrial Disorder

According to Saol, the CRL included specific requirements that “would take several years and require significant financial resources.”

US FDA deems Sun Pharma's Halol plant not compliant with its manufacturing rules

Indian drugmaker Sun Pharmaceutical Industries said on Tuesday the U.S. Food and Drug Administration had determined that its Halol plant in the western state of Gujarat was not compliant with the regulator's manufacturing rules.

FDA reductions mean less money for food safety at New Mexico Department of Agriculture

It might be time to give those veggies another wash. The New Mexico Department of Agriculture has reported its funding for a produce safety program — which stems from an agreement with the U.S. Food and Drug Administration — has been reduced by nearly 40% in the current fiscal year,
Ophthalmology Times3h

Sandoz and Regeneron reach agreement over biosimilar dispute

Sandoz received FDA approval for its biosimilar Enzeevu (aflibercept-abzv) on August 12, 2024. It has the same dosage form, route of administration, and presentation as the reference medicine, Eylea from Regeneron.

AliveDx announces U.S. Food and Drug Administration (FDA) 510(k) submission for its MosaiQ AiPlex® Vasculitis (VAS) assay.

AliveDx, the global in-vitro diagnostics company that aims to transform patient care, today announces that it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Vasculitis (VAS) assay*.
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