FDA
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FDA Updates Draft Guidance on Medical Foods
On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions…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…
FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App
On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter”…