J&J Company Pleads Guilty to Misbranding for Off-Label Marketing
On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen…
Food & Drug Blog
FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company
On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against…
FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices
On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device…
FDA’s CFSAN Announces Plan for Program Priorities
On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory…
FDA Approves Botox Cosmetic for New Intended Use
On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and…
FDA Updates Draft Guidance on Medical Foods
On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions…
FDA Publishes Final Rule on Gluten-Free Labeling
On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, “Food Labeling; Gluten-Free Labeling of…
FDA Considering Rulemaking for Menthol Cigarettes
On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to…
FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs
On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic…
FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products
On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new…