The Food and Drug Administration (FDA) recently issued a draft guidance for manufacturers of human and animal food who want the labels of their products to indicate whether (or not) the products include ingredients derived from genetically engineered plants. The FDA states that its primary interest in the topic is to ensure such labels are …
Category Archives: Regulatory News
FDA Commissioner Outlines Critical Time Ahead for Agency
FDA Acting Commissioner Stephen Ostroff told attendees on Tuesday at RAPS’ Regulatory Convergence that he’s seeing an “unusual confluence” of events, particularly as the House-passed 21st Century Cures legislation makes its way through the Senate, and as user fee negotiations have to be wrapped up by January 2017. “All I have to say is stay tuned, …
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FDA Approves First-Of-Its-Kind Product for the Treatment of Melanoma
The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
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.