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 …
By Ricardo Carvajal – Among the myriad proposals to overhaul the nation’s ailing food safety system, at least one calls for splitting off FDA’s food safety programs and incorporating them into a new Food Safety Administration ("FSA") within the U.S. Department of Health and Human …
In the latest “Enforcement Corner” column for the Food and Drug Law Institute’s Update publication, Hyman, Phelps & McNamara, P.C. attorneys JP Ellison and John R. Fleder discuss the indictment, trial, conviction, and sentencing of Berkeley Nutraceuticals’ former in-house counsel Paul Kellogg. Mr. Kellogg’s conviction …
By Jennifer B. Davis – Earlier this week, the United States Court of Appeals for the Eleventh Circuit in Atlanta issued its opinion in United States v. Endotec, Inc., an appeal from the United States District Court for the Middle District of Florida. We previously …
By Kurt R. Karst – Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA concern 14 narcotic drug products, including morphine sulfate, hydromorphone, and oxycodone. The Warning Letters direct …
By Kurt R. Karst – Last week, the U.S. Government Accountability Office (“GAO”) issued a report, titled “Nonprescription Drugs: Considerations Regarding a Behind-the-Counter Drug Class.” The report updates the Office’s 1995 report on the same topic (see our previous post here). The updated report was requested …
