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 …
By Kurt R. Karst – We learned earlier today that Michael M. Landa, Esq. was named as FDA’s new Acting Chief Counsel. Mr. Landa, who will assume his new role on April 13, 2009, has a long history with FDA. Since July 2004, Mr. Landa …
By Jennifer B. Davis – The April 9, 2009 Federal Register will contain the official notice of an FDA order requiring manufacturers of 25 types of Class III “preamendments” devices to submit information on such devices, including adverse safety and effectiveness data not already submitted …
By Kurt R. Karst – Earlier today, FDA announced the approval of Novartis’ combination drug product COARTEM (artemether; lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms. Accompanying the approval is the first Priority Review Voucher …
By Kurt R. Karst – FDA’s September 1999 guidance document, “Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act,” includes a section addressing the following question: “If my study qualifies for pediatric exclusivity, to what will the period of pediatric …
By Ricardo Carvajal – FDA has announced that it will hold a public meeting on “economically motivated adulteration” to foster discussion about ways that FDA-regulated industries can “better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health …
By JP Ellison – In U.S. v. Palazzo, the Fifth Circuit recently reversed a trial court’s decision to dismiss criminal charges against a clinical investigator based upon violation of 21 C.F.R. § 312.62(b), which requires such investigators “to prepare and maintain adequate and accurate case …
By Kurt R. Karst – We previously reported on a lawsuit filed in July 2008 by PhotoCure ASA (“PhotoCure”) against the U.S. Patent and Trademark Office (“PTO”) after the PTO denied PhotoCure’s application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,034,267 (“the …
