By Kurt R. Karst – FDA's recent approval of an ANDA submitted by Perrigo R&D Company ("Perrigo") for a generic version of the over-the-counter drug MONISTAT 1 Combination Pack (1200 mg miconazole nitrate vaginal insert and 2% miconazole nitrate cream) contains some interesting language …
By Diane B. McColl & Ricardo Carvajal – It’s here! FDA’s Center for Veterinary Medicine (“CVM”) finally implemented a "generally recognized as safe" (“GRAS”) notification program for use of ingredients in animal feed or pet food. We have waited for this program since 1997, when it …
By Ricardo Carvajal – Kellogg Company has agreed to FTC’s expansion of the settlement order that the company entered into in July 2009 regarding false claims that Frosted Mini-Wheats improve children’s attention (see our prior post here). At issue now are “dubious health claims” that Rice …
By Kurt R. Karst – Earlier this year, the U.S. Patent and Trademark Office (“PTO”) denied an application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,869,939 (“the ‘939 patent”). The ‘939 patent is one of four patents listed in FDA’s Orange Book …
By Kurt R. Karst – Last week’s 29-page decision by the U.S. District Court for the Eastern District of Pennsylvania in In re Budeprion XL Marketing & Sales Litigation is yet more affirmation that lower courts are broadly reading and applying the U.S. Supreme Court’s …
By Ricardo Carvajal & Diane B. McColl – The Alliance for Natural Health (“ANH”) has prevailed on summary judgment in its court challenge to FDA’s denials of, and restrictions on, certain qualified health claims regarding selenium and cancer. The decision marks the latest chapter in …
By Susan J. Matthees – FDA has denied a Citizen Petition requesting that FDA require drug and device companies to submit data only from non-animal test methods ("NATMs") whenever NATMs are available. The Citizen Petition was submitted on behalf of the Mandatory Alternatives Petition Coalition …
By William T. Koustas – As we have previously reported (here, here, and here), the FTC has delayed enforcement of its Red Flags Rule (“the Rule”) several times since its original effective date of November 1, 2008. Now, some in Congress have requested that the …
By Ricardo Carvajal – Senators Harkin and Hatch have introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010 (S. 3414). The statement of findings notes that FDA has been slow to implement the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, and …
By Kurt R. Karst – Earlier this week, we reported on the latest in the ongoing saga over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) – an order from the U.S. …
By Ricardo Carvajal – FDA has revised its draft guidance on the Reportable Food Registry (“RFR”) to address the new electronic portal for submission of reports, and in response to recent questions that the agency received from industry. Among the more significant changes and additions: A …
By John R. Fleder & Ricardo Carvajal – The Federal Trade Commission ("FTC") has announced a second opportunity for public comment on its proposed issuance of compulsory process orders to 48 food and beverage firms. If those orders are issued, the FTC will demand information …
By Kurt R. Karst – In a somewhat unusual move, the U.S. Supreme Court has asked the U.S. Department of Justice (Solicitor General of the United States) to weigh in on generic drug preemption. The move signals that the Court has continued interest in this …
By Ricardo Carvajal – FDA announced that Reportable Food Registry ("RFR") reports can now be submitted through the new FDA-NIH Safety Reporting Portal, which will also accept reports about problems with pet food, animal drug adverse event reports, and human gene transfer clinical trial adverse …
By Kurt R. Karst – Late last Friday, in a case that is full of twists and turns, the U.S. District Court for the Eastern District of Virginia (Alexandria Division) added another twist (or turn) and ordered the U.S. Patent and Trademark Office (“PTO”) to …
