Labeling
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 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 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 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…
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…
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FDA Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease
On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for…
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…
FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week
This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by…
FDA Warns of Recall Due to Undeclared Milk Derivatives in Several Beverage Products
On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers…