FDA
Company’s Operations Halted for Violating FDA Food Labeling Rules
On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of…
Supreme Court to Review Design Defect Case against Generic Drug Company
On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett.…
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…