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 …
By Susan J. Matthees – Last year we reported that FDA had moved to dismiss a lawsuit alleging that FDA had improperly denied HiFi DNA Tech, LLC’s (“HiFi’s”) petition for reclassification of an HPV nested DNA polymerase chain reaction detection device from Class III to Class …
By Kurt R. Karst – On April 14, 2009, the Federal Trade Commission (“FTC”) announced that Chairman Jon Leibowitz has appointed six senior new staff members, including former Public Citizen Director David C. Vladeck. According to the FTC announcement: David C. Vladeck, who will serve as Director …
By Kurt R. Karst – We recently reported on a complaint filed in the U.S. District Court for the District of Columbia by Actavis Elizabeth LLC (“Actavis”) against FDA in which Actavis requested the court to enter an injunction directing FDA to rescind the Agency’s …
By Ricardo Carvajal – The USDA Animal and Plant Health Inspection Service (“APHIS”) will hold a public meeting on April 29 and 30 to foster discussion of certain issues that were raised during the comment period for its proposed rule on Importation, Interstate Movement, and Release …
By Kurt R. Karst – Over the past year or so, the U.S. Court of Appeals for the Federal Circuit has addressed the proper jurisdictional scope of the “case or controversy” requirement under Article III of the U.S. Constitution for a court to have jurisdiction …
By Kurt R. Karst – We previously reported on FDA’s recent drug-based marketed unapproved drug enforcement action concerning certain narcotics. In that case, FDA issued 9 Warning Letters to companies concerning 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. Late on April 9, 2009, FDA …
