By Wes Siegner & Ricardo Carvajal – FDA has issued a warning letter to General Mills in which the agency alleges “serious violations” of the FDC Act in the label and labeling of Cheerios cereal. Specifically, FDA contends that the following label claims make Cheerios …
By Ricardo Carvajal – On May 11, FDA announced the condemnation and forfeiture of $1.3 million worth of dietary supplements marketed to body builders because the supplements contain “one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to …
By Kurt R. Karst – In a recent unpublished opinion issued by the U.S. District Court for the District of New Jersey, the court ruled that the Patent Term Extension (“PTE”) granted by the U.S. Patent and Trademark Office (“PTO”) with respect to U.S. Patent No. …
By Ricardo Carvajal – In two studies recently published in Nature (see here and here) scientists report success applying a novel technique to more precisely insert genes conferring herbicide resistance into corn and tobacco. In addition to enabling greater precision, the technique results in stable …
By Christine P. Bump – The State of New Jersey announced this week that it had entered into a landmark agreement with Synthes, Inc. to settle allegations that Synthes failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Synthes …
By Kurt R. Karst – FDA’s recent decision to grant in part and deny in part a citizen petition concerning generic versions of DORYX (doxycycline hyclate) Delayed-Release Tablets reaffirms FDA’s policy that in order for two drug product to be in the same “dosage form,” …
By John R. Fleder – On May 5, 2009, the White House announced that President Obama intends to nominate former South Carolina State Superintendent of Education Inez Moore Tenenbaum as Chair of the United States Consumer Product Safety Commission (“CPSC”) and also University of North Carolina …
By Ricardo Carvajal – At its public meeting on economically motivated adulteration ("EMA"), FDA got no shortage of suggestions on how to better prevent, detect, and address instances of EMA. FDA called the meeting “to stimulate and focus discussion about ways in which the food …
By Carrie S. Martin – FDA announced on April 30, 2009, that all botulinum toxin products will now require a Risk Evaluation and Mitigation Strategy ("REMS") and safety labeling changes, including a boxed warning, due to the risk of spread of botulinum toxin effects from …
By Carrie S. Martin – On April 29, 2009, FDA issued a final rule requiring new labeling for over-the-counter (“OTC”) pain relievers and fever reducers, also known as internal analgesic, antipyretic, and anti-rheumatic drug products (“IAAAs”). The rule revises 21 C.F.R. Part 201 to require manufacturers …
By Kurt R. Karst – “Is the Obama Administration Poised to Undo FDA’s Preemption Stance?” We posed this question in a post earlier this year after a pre-publication version of a 96-page final rule concerning new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal …
By Ricardo Carvajal – FDA has announced that it expects compliance with its final rule prohibiting the use of certain cattle origin materials (e.g., brains and spinal cords from cattle 30 months of age and older) in the food or feed of all animals on …
By Susan J. Matthees – At the request of the Centers for Disease Control and Prevention ("CDC"), FDA announced last night that it would issue Emergency Use Authorization ("EUA") of flu medicines and diagnostic tests in response to the recent swine flu outbreak. Two antiflu …
By John R. Fleder – On April 28, 2009, the United States Supreme Court issued an important ruling on an administrative law issue. In FCC v. Fox Television Stations, the Court by a 5-4 vote ruled that the FCC had properly explained its decision that …
By William T. Koustas – Earlier this month, FDA announced that Institutional Review Board (“IRB”) Coast IRB, LLC of Colorado Springs, Colorado (“Coast”) voluntarily agreed to stop reviewing new FDA-regulated studies and halt enrollment of new subjects in ongoing trials after FDA determined it committed …
