FDA
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…
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…
FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease
On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for…
Study Prompts OIG to Call for Further Training of FDA Medical Device Reviewers
On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding…