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FDA

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 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…

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…