FDA

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FDA Updates Draft Guidance on Medical Foods

On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions…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…

FDA Publishes Overview of Regulatory Requirements for Food Businesses

On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to…

FDA Issues Final Rule on Prior Notice for Imported Food

On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the…