By Diane B. McColl & Riëtte van Laack – On June 25, 2009, Ovos Natural Health Inc. ("Ovos") filed a citizen petition asking FDA to promulgate a regulation allowing use of homotaurine, a new dietary ingredient, in dietary supplements under sections 201(ff)(3)(B)(ii) and 301(ll)(2) of …
By Kurt R. Karst – We recently reported on a Complaint and a Motion for Preliminary Injunction Teva Pharmaceuticals USA, Inc. (“Teva”) filed in the U.S. District Court for the District of Columbia against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & …
The Consumer Products Safety Commission (“CPSC”) yesterday announced that former South Carolina State Superintendent of Education Inez Moore Tenenbaum has been sworn in as the ninth CPSC Chairman. We previously reported on her nomination and President Obama’s plans to expand the CPSC from the current …
By Kurt R. Karst – There has been a frenzy of activity on Capitol Hill in recent days over Follow-On Biologics (“FOBs”). At least four different proposals – all titled as the “Biologics Price Competition and Innovation Act of 2009” – have reportedly been floated …
By Anne Marie Murphy – FDA’s final rule requiring IRBs that review FDA-regulated clinical investigations to register through a system maintained by the Department of Health and Human Services (“HHS”) takes effect on Tuesday, July 14, 2009. In the Federal Register notice announcing the final …
Sigh. We've been dragged (kicking and screaming) into the 21st Century. So, we've put down our quill pens and are now twittering at www.twitter.com/fdalawblog. Many of our "tweets" will link to the blog, but we will also be putting up other FDA-related news and updates …
By Kurt R. Karst – The recent challenge to FDA’s five-year New Chemical Entity (“NCE”) exclusivity determination concerning the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules and the reportedly ongoing debate over whether to grant NCE exclusivity with respect to certain pancreatic enzyme products are not the …
By Kurt R. Karst – Over the past week, generic drug manufacturer Apotex, Inc., which we understand recently parted ways with the generic drug trade association, GPhA, has filed two similar declaratory judgment actions in an effort to “unpark” 180-day exclusivity eligibility that is reportedly …
By Susan J. Matthees – The Institute of Medicine (“IOM”) has released a report and a list of priorities for comparative effectiveness research to be funded by The American Recovery and Reinvestment Act of 2009 (the stimulus bill). The IOM list contains 100 priority topics, …
By William T. Koustas & John R. Fleder – FDA-regulated businesses are certainly closely regulated by FDA and other federal agencies. However, one area that many of these businesses erroneously believe does not affect them is the federal laws and regulations that apply to identity theft. The …
