FDA Attorney

FDA Approves Orphan Drug to Treat Aplastic Anemia

On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment.…

Food Seasonings Recalled Due to Undeclared Allergens

On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound…

Marshals Seize Supplements with Undeclared Drug Ingredients

On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters…

FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a…

FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch

On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women's bladder control…

FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree…

FDA Warns Online Cigarette Retailers for Marketing Violations

In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes,…

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit…

Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales…

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…