U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that products that emit radiation
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
A study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.
FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.
The FDA is alerting patients of a safety concern regarding diabetes devices that rely on a smartphone to deliver critical safety alerts. The FDA has received medical device reports in which users report these alerts are not being delivered or not being heard.
The FDA approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Today, the U.S. Food and Drug Administration authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review.
FDA issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA announces a proposed rule requiring food manufacturers to display a front-of-package (FOP) nutrition label on most packaged foods. The proposed FOP nutrition label, referred to as the Nutrition Info box, would display nutrition information interpreting the saturated fat, sodium, and added sugars
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The FDA issued draft guidance that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials evaluating investigational medical products and/or that are conducted or supported by the Department of Health and Human Services.
The FDA issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality.
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.
The FDA published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care used to estimate the amount of oxygen carried in the blood – across the range of skin pigmentation.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products
FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA approved Symvess, the first acellular tissue engineered vessel for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
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