On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …
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 treat the HIV-1 infection in adult individuals who have not previously received treatment for the infection. Manufactured by Gilead Sciences, …
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 “Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, …
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 recall initiated by GH Foods CA, LLC. The recall covers a variety of products containing certain onions distributed by Gills …
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 the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve …
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 to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to …
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 will result in the largest settlement of its kind in the United States. In particular, the pharmaceutical giant will be …
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 widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s …
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 the problem of drug shortages for key lifesaving drugs. According to the Report, the shortages are largely affecting the availability …
Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request
On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was …