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…
Food & Drug Blog
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”…
FDA Investigates the Safety of Caffeine in Food
On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of…
FDA Issues Warning Letters to Online Cigarette Companies
In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many…
FDA Publishes CPG on Food Facility Registration
On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food…
Company’s Operations Halted for Violating FDA Food Labeling Rules
On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of…
Supreme Court to Review Design Defect Case against Generic Drug Company
On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett.…
FDA Approves Orphan Drug to Treat Aplastic Anemia
On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment.…