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 Ricardo Carvajal & John R. Fleder – In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which …
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 JP Ellison & John R. Fleder – The Supreme Court’s April 22, 2009 decision in NKEN v. HOLDER relates to expediting the removal of aliens from this country. The decision merits mention here because it preserves the ability of appellate courts to stay government action pending …
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 Ricardo Carvajal & John R. Fleder – On April 20, 2009, the U.S. Supreme Court let stand the Third Circuit’s decision in Fellner v. Tri-Union Seafoods. As we discussed in a prior posting, Fellner’s lawsuit contends that Tri-Union is guilty of negligence under New Jersey …
By Ricardo Carvajal & John R. Fleder – On April 17, 2009, DOJ’s Office of Information Policy (“OIP”) issued guidance to federal agencies on President Obama’s FOIA Memorandum of January 21st and Attorney General (“AG”) Holder’s subsequent FOIA March 19th guidelines. The President’s FOIA memorandum directed …
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 …
