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 …
By Kurt R. Karst – We previously reported (here and here) on concerns as to whether a company submitting an ANDA (or a 505(b)(2) application) containing the results of an in vivo bioequivalence study must certify on Form FDA 3674 that new Public Health Service …
By Ricardo Carvajal – According to a CVM Animal Feed Safety System update, the CVM Division of Animal Feeds has formed an Ingredient Safety Team that will begin accepting GRAS notification submissions for animal feed ingredients as part of a pilot program starting this summer. …
By Kurt R. Karst – FDA’s April 15th decision to approve ANDAs for generic versions of Topiramate Sprinkle Capsules signals a new FDA interpretation of the 180-day generic drug exclusivity provisions of the FDC Act, which were amended in December 2003 under Title XI of …
By William T. Koustas – On April 15th, the Department of Justice announced that the U.S. has entered into a global criminal and civil settlement with Quest Diagnostics Inc. (“Quest”) and its subsidiary Nichols Institute Diagnostics (“NID”). NID pleaded guilty to a felony charge of misbranding …
