Western Mixers Produce & Nuts, Inc., Ontario, California is recalling: First Street brand, Dark Chocolate Raisins, 9 oz., because the product may contain undeclared dark chocolate peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergi
Survodutide led to significant weight loss in adults with obesity and without diabetes, according to results from the randomized, placebo-controlled SYNCHRONIZE-1 trial published June 7 in NEJM.
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.
FDA is concerned about telehealth companies promoting compounded drugs, including glucagon-like peptide-1 receptor agonists (GLP-1s) and other drugs, with false or misleading claims.
The ACC submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the fiscal year 2027 Inpatient Prospective Payment System (IPPS) proposed rule.
FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada. Learn more.
In the push toward a more seamless, digitally enabled future, it’s important we understand exactly how this rush to interoperability may actually harm patients, instead of helping, and what we can do to make sure they keep pace. The post Don’t Leave Healthcare’s Greatest Asset Behind on the Road to Interoperability appeared first on MedCity News .
FDA reviews drug shipments at land and seaports, courier hubs and international mail facilities to determine whether they are admissible into the U.S. FDA uses a multi-layered, risk-based approach to identify violative imported drugs, combining data screening and physical examinations.
An investigational new drug (IND) imported for use in clinical studies must be covered by an IND application, unless exempt per 21 CFR 312.2. The company should submit the IND to FDA before importing the drug into the U.S.
Active pharmaceutical ingredients (APIs) imported or offered for import into the U.S. must comply with all the applicable requirements and regulations under the Food Drug & Cosmetic (FD&C) Act and Title 21 of the Code of Federal Regulations (21 CFR).
FDA reviews requests and may grant permission in certain circumstances for a manufacturer to import a drug in anticipation of the drug receiving FDA approval. When approved, these pre-launch activities importation requests, or PLAIRs, allow drug sponsors to import unapproved finished drugs.
Over-the-counter (OTC) or non-prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).
FDA verifies that drugs imported or offered for import into the U.S. meet federal law requirements at the time of import to protect patients and consumers.
Prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).