FDA
Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional
On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales…
FDA Actions Highlight New Authority under FSMA
On November 26, 2012, the U.S. Food and Drug Administration (“FDA”) suspended the food facility registration of Sunland, Inc., a…
FDA Investigates Illnesses Linked to Energy Drinks and Supplements
On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of…
Jimmy Dean Initiates Recall for Failure to Declare Allergens
On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of…
FDA Warns Company for Marketing Medical Device
On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a…
FDA Targets Online Pharmacies in International Efforts
On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of…
FDA Approves MS Drug, Noting Boxed Warnings
On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured…
FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments
On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in…
FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors
On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated…
FDA Approved Combination Pill for HIV Treatment
On August 27, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of Stribild, a drug intended to…