Hyman, Phelps & McNamara’s Robert A. Dormer will be speaking at the American Conference Institute’s upcoming conference, “Orphan Drugs and Rare Diseases – Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.” The conference will take place on November 28th and 29th …
By Ricardo Carvajal – The Center for Science in the Public Interest (“CSPI”) is taking on caffeination and fortification of foods with renewed vigor. In a letter to FDA/CFSAN’s Office of Compliance, CSPI alleges that certain foods to which caffeine is added “appear to violate [FDA’s] …
By Jennifer D. Newberger – FDA is amending its proposed rule to establish a unique device identification (“UDI”) system, published on July 10, 2012 (see our previous post here), to meet the requirements of section 614 of the Food and Drug Administration Safety and Innovation Act …
By Jess Ritsick & Bill Koustas – The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to …
By Kurt R. Karst – Earlier this week, Cumberland Pharmaceuticals Inc. (“Cumberland”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s November 7, 2012 denial of a Citizen Petition (Docket No. FDA-2012-P-0507) and approval of InnoPharma, Inc.’s (“InnoPharma’s”) ANDA …
For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks over at U.S. News & World Report, who once again teamed up with Best Lawyers …
Hyman, Phelps & McNamara, P.C. is pleased to announce that David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products. The conference, titled “EU and US Regulatory Issues for …
By Kurt R. Karst – Back in August, we posted on a Petition for Writ of Certiorari filed by Mutual Pharmaceutical Company, Inc. (“Mutual”) appealing a May 2, 2012 decision from the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical …
By Ricardo Carvajal – FDA published a draft Compliance Policy Guide ("CPG") that sets out enforcement criteria for ackee fruit products that contain hypoglycin A, a toxin that is naturally present in the fruit. Adverse effects of consuming the toxin can range from none to vomiting, …
By Kurt R. Karst – FDA’s opening brief in the Agency’s appeal of a March 27, 2012 Memorandum Opinion and accompanying Order issued by Judge Richard J. Leon of the U.S. District Court for the District of Columbia (as modified by a June 22, 2012 …
By Karla L. Palmer – The Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations issued a Majority Memorandum announcing that it is holding a hearing titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” The hearing will begin at 10:00 am at Room …
By Jeff Wasserstein & Dara Katcher Levy – FDA’s Office of Prescription Drug Promotion (“OPDP”) recently issued an untitled letter to Cornerstone Therapeutics, Inc. relating to Cornerstone’s drug Curosurf (see here and here). The allegations in the letter are unremarkable and contain the usual claims …
By Kurt R. Karst – From time to time throughout Hatch-Waxman history the question has come up: What court decisions terminate a 30-month litigation stay arising as a result of a timely filed patent infringement action in response to a Paragraph IV certification (in either …
By Jennifer D. Newberger – CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized. There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all …
By Kurt R. Karst – FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of …
