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…
FDA Publishes Final Guidance Explaining Egg Safety Rule
On August 20, 2012, the U.S. Food and Drug Administration (“FDA”) announced the availability of the final guidance document entitled…
Listeria-Laden Onions Spur Recalls throughout United States
On July 28, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release notifying consumers of a voluntary…
FDA Proposes New Unique Identifier System for Medical Devices
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in…
FDA Approves First At-Home HIV Test
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used…
GlaxoSmithKline to Pay $3 Billion in Settlement with Government
On July 2, 2012, GlaxoSmithKline (“GSK”) announced its intention to plead guilty in its ongoing healthcare fraud case in what…
FDA Warns Makers of RockStar Coffee & Energy Products
On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the…
House Oversight Committee Finds that FDA Actions Cause Drug Shortages
On June 15, 2012, the U.S. House of Representatives Committee on Oversight and Government Reform issued a Staff Report, detailing…