back to homepage

Regulatory News

Food, Drug & Device Law Alert – FDA Issues Draft Guidance on Voluntary Labeling of GMO Foods

The Food and Drug Administration (FDA) recently issued a draft guidance for manufacturers of human and animal food who want the labels of their products to indicate whether (or not)

Read More

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

Read More

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.

Read More

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.

Read More

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

Read More