Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. The charges were brought by the U.S. Attorney’s Office for the Eastern District of Kentucky.
Category Archives: Drug Safety Information Podcasts
FDA issues guidance to support the responsible development of nanotechnology products
Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Producer of tainted dietary supplements sentenced in federal court
Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.
FDA approves Sivextro to treat skin infections
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.
FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.
FDA and EPA issue draft updated advice for fish consumption
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued updated draft advice on fish consumption. The two agencies have concluded pregnant and breastfeeding women, those who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain important developmental and health benefits. The updated draft advice is consistent with recommendations in the 2010 Dietary Guidelines for Americans.
FDA approves the first antihemophilic factor, Fc fusion protein for patients with Hemophilia A
The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
FDA launches openFDA to provide easy access to valuable FDA public data
Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.
FDA approves first generic versions of celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
FDA to require warnings on sunlamp products
Today, the U.S. Food and Drug Administration issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices. The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.