On March 31, 2008, FDA published a Federal Register notice announcing the availability of Compliance Policy Guide (“CPG”) § 500.500, which sets “guidance levels” for 3-MCPD in acid-hydrolyzed protein (“acid-HP”) and Asian-style sauces. 3-MCPD is a chloropropanol, and chloropropanols have been identified as carcinogens. Under …
On March 24, 2008, FDA asked the U.S. District Court for the District of Connecticut to dismiss a January 22, 2008 Amended Complaint alleging that the Agency improperly denied HiFi DNA Tech, LLC’s petition for reclassification of an HPV nested DNA polymerase chain reaction (PCR) …
Earlier this year, we reported on the U.S. District Court for the District of Columbia’s January 24, 2008 order dismissing Nu-Pharm Inc.’s complaint against FDA seeking declaratory and emergency injunctive relief with respect to Nu-Pharm’s ANDA #77-615 for a generic version of Abbott Laboratories’ DEPAKOTE …
In our October 2007 summary and analysis of the FDA Amendments Act (“FDAAA”), Hyman, Phelps & McNamara, P.C. noted that FDAAA § 912, concerning a new prohibition against foods to which drugs or biological products are added, is “of potential significance to the development of …
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack and John R. Fleder discusses a recent court ruling showing the potential perils faced by a company and its officers who aggressively defend their position. In United States v. Kaminski, the …
Welcome to the wonderful world of blogging, Dr. von Eschenbach! Yep, just like his boss, Department of Health and Human Services Secretary Michael Leavitt, who started “Secretary Mike Leavitt’s Blog” last year, FDA Commissioner, Dr. Andrew von Eschenbach, has started a blog as well – …
On March 21, 2008, the California EPA Office of Environmental Health Hazard Assessment (“OEHHA”) announced a workshop scheduled for April 18, 2008 to seek public input on the potential regulation of nutrients, such as vitamins and minerals, under Proposition 65 (the Safe Drinking Water and …
Earlier today, FDA issued a Federal Register notice notifying holders of applications for certain prescription drug products approved under FDC Act § 505(b) (NDA) or § 505(j) (ANDA) and biological products licensed under § 351 of the Public Health Service Act that they will be …
FDA and the University of Rhode Island College of Pharmacy will co-sponsor an interactive forum from June 30 through July 1, 2008 at the Hyatt Regency in Bethesda, Maryland on how and how not to communicate with FDA’s Office of Generic Drugs (“OGD”). Forum presenters …
Last week, the Pennsylvania Court of Common Pleas of Philadelphia County (the lowest court of general jurisdiction in Pennsylvania) ruled in Clark v. Pfizer, Inc., Case No. 1819 (June Term 2004) – a class action lawsuit in which the plaintiffs allege that Parke-Davis (then a …
Earlier this month, we reported on a lawsuit filed by Teva Pharmaceuticals USA against FDA in the U.S. District Court for the District of Columbia concerning the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange Book covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets. …
Last year, in our post titled “180-Day Exclusivity Forfeiture – A Zen Moment,” we reported on a case in which FDA took a stance with respect to the forfeiture of 180-day exclusivity eligibility that is reminiscent of the old “if a tree falls in the …
Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that Ricardo Carvajal has joined the firm as Of Counsel. From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA’s Office of Chief Counsel, where he handled issues concerning foods (including conventional …
Last month, we reported on the U.S. Supreme Court’s 8-1 decision in Riegel v. Medtronic, in which the Court provided a definitive decision preempting state tort law claims for medical devices subject to an approved Premarket Approval Application. Immediately after the decision was issued, some members …
Last Friday, Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) announced the introduction of H.R. 5629, the “Pathway for Biosimilars Act.” We previously reported on a draft version of the bill circulated on Capitol Hill in February 2008. H.R. 5629 will be referred to the …
