By Michelle L. Butler & Kurt R. Karst – As we recently reported, the U.S. District Court for the District of Columbia granted Depomed Inc.’s ("Depomed’s") Motion for Summary Judgment and ordered FDA to recognize orphan drug exclusivity for Gralise (gabapentin) Tablets “without requiring any proof …
By Jennifer D. Newberger – On August 19, 2014, FDA finalized its guidance document, “FDA Decisions for Investigational Device Exemption Clinical Investigations,” which was issued in draft in June 2013. The final guidance is largely similar to the draft, with the exception of the pre-decisional IDE …
By Jennifer M. Thomas & Anne K. Walsh – French device maker PREVOR won another victory against FDA in litigation involving FDA’s interpretation of the statutory definition for “device.” The first suit, as readers may recall (see our previous post here), resulted in a finding from …
By Riëtte van Laack – This case dates back to November 2004, when the FTC filed a complaint in the United States District Court for the Northern District of Georgia, alleging that defendants, including the National Urological Group, Inc., Hi-Tech Pharmaceuticals, Inc., Jared Wheat and Stephen …
By Kurt R. Karst – If you guessed that the cover of the publication listing biological products licensed under the Public Health Service Act (“PHS Act”), including licensed biosimilar and interchangeable biological products, would be “purple,” then you guessed correctly. The “Purple Book,” which is more …
By Ricardo Carvajal – FDA has made no secret of its increasing investment in, and reliance on, databases of genetic information to investigate outbreaks of foodborne illness. In public presentations, compliance officials have lauded the utility of PFGE and PulseNet, the Whole Genome Sequencing (WGS) Program, …
By Kurt R. Karst – In the 2003 movie “Freaky Friday,” based on the novel of the same name by Mary Rodgers, teenager Anna Coleman (played by Lindsay Lohan) and her mother, Tess Coleman (played by Jamie Lee Curtis), have their souls switched due to an …
By Kurt R. Karst – Last week, Connecticut Attorney General George Jepsen announced the submission of extensive comments to FDA that press the Agency to “exercise its discretion to immediately waive the 180-day waiting period and approve the sale” of generic versions of AstraZeneca LP’s NEXIUM …
By Kurt R. Karst – Nearly two years after Depomed, Inc. (“Depomed”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s denial of orphan drug exclusivity for GRALISE (gabapentin) Tablets, the court (Judge Ketanji Brown Jackson) has finally ruled in …
In conjunction with Virginia CLE, Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal and Senior Counsel Brian Donato are presenting a 2-hour CLE telephone seminar that will provide an overview of the Food Safety Modernization Act and its anticipated impact on food businesses. The seminar is directed …
By Kurt R. Karst – It was just a few months ago that we posted on what might have been the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and that does not …
An article set to be published in the Albany Law Review in Spring 2015, titled “Drug Diversion Administrative Revocation and Application Hearings for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters,” explores the increasingly complex and nuanced practice of administrative law before …
By Kurt R. Karst – With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) – we’ve had renewed …
By Kurt R. Karst – The hope is that years from now (but hopefully not too many years), once the review and performance metrics FDA agreed to as part of the Generic Drug User Fee Amendments are in full effect and 10-month ANDA reviews (resulting in …
By Ricardo Carvajal & Diane B. McColl – The Grocery Manufacturers Association ("GMA") announced an initiative designed to “improve the process and increase transparency for making Generally Recognized As Safe ("GRAS") determinations of ingredients added to food.” The initiative includes the following five elements: Development by independent …
