By Kurt R. Karst – In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371) concerning their testosterone gel 1% drug products – AbbVie’s ANDROGEL (NDA No. 021015) and Auxilium’s TESTIM …
By Kurt R. Karst — Beginning in 1999, around the time FDA issued a (still) draft guidance document on 505(b)(2) applications, and lasting until about 2009, this blogger taught an introduction to drug law course at FDA to FDAers. The focus of my talk was – surprise, surprise …
By Kurt R. Karst – Our FDA Citizen Petition Tracker is littered with petitions and petitions for reconsideration submitted to FDA over the past 18 months requesting that the Agency recognize a period of 5-year New Chemical Entity (“NCE”) exclusivity for certain Fixed-Dose Combination Drugs (“FDCs”) …
By Kurt R. Karst – Earlier this week, and just a day after the second anniversary of the 2012 FDA Safety and Innovation Act that, among other things, includes the Generic Drug User Fee Amendments (“GDUFA” ), FDA announced the release of two draft guidance documents …
By Kurt R. Karst – Ever since the FDC Act was amended in November 1997 by the the FDA Modernization Act (“FDAMA”) to add a new section creating a period of “pediatric exclusivity,” we’ve had more than a passing interest in the provision. In fact, it …
By Kurt R. Karst – It’s been quite a while since we last posted on the so-called “RLD (Reference Listed Drug) Theory of Liability.” It’s the theory put forward by plaintiffs’ attorneys in a lot of failure-to-warn generic drug product liability cases which posits that FDA’s …
By Kurt R. Karst – FDA’s recent posting of two Warning Letters (here and here) to companies that failed to pay Generic Drug User Fee Amendment (“GDUFA”) facility user fees for Fiscal Year 2014 (“FY14”) – for a grand total of three GDUFA Warning Letters thus …
By Kurt R. Karst – Although we’re not patent attorneys, we’re smart enough to know that the September 16, 2011 enactment of the Leahy-Smith America Invents Act (“AIA”) signaled a sea change in the patent world. Indeed, the effects of the AIA were immediately felt in …
By Kurt R. Karst – After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms to account for new non-patent marketing exclusivities. First there was the addition of …
By James E. Valentine – On June 11, 2014, a panel before the House Energy and Commerce Committee’s Subcommittee on Health hosted its second hearing on the 21st Century Cures Initiative. The Subcommittee sought input on whether current economic and regulatory incentives are sufficient to encourage …
By Kurt R. Karst – Although this blogger didn’t catch the episodes of The Six Million Dollar Man that originally aired in the mid-1970s, I did see them once they were syndicated. As I remember it, the opening theme and narration to the popular television show starring …
By Kurt R. Karst – In what might very well be the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and not concerning a patent use code), last week the U.S. District Court …
By Kurt R. Karst – FDA’s Pre-Launch Activities Importation Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program. Briefly, the PLAIR program allows, on a case-by-case basis and …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Kurt R. Karst – We’re not sure if it was merely the passage of time or something else that relieved the constipation, but FDA has finally acted on an October 24, 2008 Notice for an Opportunity for Hearing (Docket No. FDA-2008-N-0549) proposing to withdraw approval …
