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…
Food & Drug Blog
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FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease
On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for…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…
FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement
On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan…
U.S. Marshals Seize Products from California Firm upon FDA ’s Repeated Finding of Violations
On May 22, 2012, the U.S. Food and Drug Administration (“FDA”) announced that U.S. Marshals, acting at the requests of…
FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War
On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful…
FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients
On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of…