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 …
By Susan J. Matthees – Last week FDA published a memorandum titled “FDA Comments on Symbols Public Hearing and Current Plans for Addressing Issues.” The memorandum responds to questions and issues raised during a September 10-11, 2007 hearing titled "Use of Symbols to Communicate Nutrition …
By Carmelina G. Allis – In June 2008, we reported that the Accreditation Council for Continuing Medical Education (“ACCME”) had issued for comment a proposed restrictive paradigm under which commercial support for continuing medical education (“CME”) would be permissible if certain conditions were met. In …
By Kurt R. Karst – FDA’s April 2009 response to a September 2007 suitability petition requesting permission to submit an ANDA for a lyophilized generic version of ZOMETA (zoledronic acid) Injection and an FDA determination that such drug product, if approved, would be therapeutically equivalent …
By Christine P. Bump – On April 22, 2009, FDA announced that it sent a letter to the manufacturer of Plan B stating that the Agency would, “upon submission and approval of an appropriate application,” permit the sale of Plan B without a prescription to …
By Carrie S. Martin – As we reported previously, FDA decided to institute a class-wide Risk Evaluation and Mitigation Strategy (“REMS”) for 24 different opioid products. FDA held a private meeting on March 3, 2009, with the 16 manufacturers of the opioid products to discuss …
By Jamie K. Wolszon & Anne Marie Murphy – On April 20th, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) issued a revised “Principles on Conduct of Clinical Trials and Communication of Clinical Trials Results.” The revision outlines, among other things, the trade group’s Principles on …
By William T. Koustas – On April 20th, the Federal Trade Commission ("FTC") announced that it has brought, and at the same time tentatively settled, charges of false advertising brought under the FTC Act against Kellogg, the world’s largest cereal maker. The FTC accused Kellogg …
