By Kurt R. Karst – Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (“Graceway”) requesting that the Agency refuse to approve Abbreviated New Drug Applications (“ANDAs”) for generic versions of Graceway’s ALDARA (imiquimod) Cream, 5%, unless such applications contain, among …
By Kurt R. Karst & Frank J. Sasinowski – We recently reported on the banner year FDA’s Office of Orphan Products Development (“OOPD”) had in 2009, surpassing the 2,000 orphan drug designation mark and designating a near-record 160 products for orphan (i.e., rare) diseases and …
By Kurt R. Karst – As we predicted, Massachusetts-based The Medicines Company (“TMC”) has sued the U.S. Patent and Trademark Office (“PTO”) and FDA in connection with the company’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) …
For heavily-regulated companies, such as those regulated by the Food and Drug Administration, it is common for companies to seek advice from in-house and outside counsel regarding whether proposed conduct would violate the law. It has become increasingly popular for federal prosecutors to target the …
By Kurt R. Karst – Is an ANDA applicant who cites a 505(b)(2) drug as the Reference Listed Drug (“RLD”) required to certify to Orange Book-listed patents covering the 505(b)(2) RLD drug as well as to Orange Book-listed patents covering the original listed drug approved …
By Ricardo Carvajal & Diane B. McColl – In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to …
By Kurt R. Karst – Now that we are a little more than six years after the December 8, 2003 enactment of Title XI of the Medicare Modernization Act (“MMA”), which, among other things, amended the FDC Act to create a new 180-day exclusivity regime …
Hyman, Phelps & McNamara, P.C.’s Josephine Torrente will be co-chairing and speaking at ACI’s upcoming two-day Risk Evaluation and Mitigation Strategies Conference. Ms. Torrente will be presenting on post-marketing safety requirements and applicants’ obligations under FDAAA. The conference is scheduled for April 19-20 at the …
By James R. Phelps – By a series of treaties, the nations of the world have given the United Nations (“UN”) a significant role in the development of systems of regulation of substances, including vitally needed medicines, that might be abused. The World Health Organization …
By Ricardo Carvajal – According to a press release issued by Senator Mark Pryor's office, Senator Pryor (D-AR) has teamed up with Senator Benjamin Cardin (D-MD) to introduce the Nanotechnology Safety Act of 2010. The bill, introduced on January 21, 2010 as S. 2942, is …
By Peter M. Jaensch & John R. Fleder – The January 21, 2010 Federal Register contains a notice that the United States Sentencing Commission has proposed amendments to the Sentencing Guidelines and their Commentary concerning corporations and other business organizations. In addition, the Commission has raised an issue …
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) surpassed the 2,000 orphan drug designation mark in 2009 and designated a near-record 160 products for orphan (i.e., rare) diseases and conditions. FDA also approved 17 orphan products in 2009, according to data …
By Kurt R. Karst – Massachusetts-based The Medicines Company (“TMC”) has lost its latest battle with the U.S. Patent and Trademark Office (“PTO”) for a Patent Term Extension for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), a drug product FDA first …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be speaking at FDLI’s upcoming Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry. Mr. Carvajal will be presenting on food safety and unintended components/contaminants in food. The conference …
By Peter M. Jaensch – On January 14, 2010, the U.S. Attorney’s Office for the District of Massachusetts issued a statement announcing the charging of Doctor Scott Reuben, a former Chief of Acute Pain at Bay State Hospital in Springfield, Massachusetts, with one count of …
