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Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program.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 Alexander J. Varond – On May 29, FDA issued its final guidance on “Expedited Programs for Serious Conditions – Drugs and Biologics.” We blogged previously on the draft guidance and each of FDA’s four expedited programs (fast track designation, accelerated approval, priority review, and breakthrough …
By Kurt R. Karst – FDA’s recent announcement that the Agency seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories (“Ascend”) is the latest, and most clear example yet of FDA taking action pursuant to the Agency’s September 19, 2011 Marketed Unapproved Drugs …
By James C. Shehan & David B. Clissold – Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells us that “a good name is better than precious ointment.” In a new draft guidance applicable …
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 …
It’s been nearly 30 years since President Ronald Reagan, on September 24, 1984, held a ceremony in the Rose Garden to sign into law the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) – better …
By Alexander J. Varond & James E. Valentine – On May 20, 2014, Hyman, Phelps & McNamara, P.C.’s Frank J. Sasinowski appeared on a panel before the House Energy and Commerce’s Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maine came one step closer to a merits ruling in a lawsuit filed last September by two Maine pharmacists, three Maine trade associations (the Maine Pharmacy Association, Maine Society of …
By Kurt R. Karst – In a May 14, 2014 Order following a hearing earlier that day, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia granted on ripeness grounds FDA’s Motion to Dismiss a lawsuit brought by Teva Pharmaceutical Industries …
By Jessica A. Ritsick & William T. Koustas – On May 8th and 9th, FDA got the ball rolling on the implementation of Title II of the Drug Quality & Security Act (“DQSA”), the Drug Supply Chain Security Act (“DSCSA”), by hosting a public workshop for …
By James C. Shehan – As previously reported here, in February 2012, FDA released three highly-anticipated guidances on biosimilars. Those of us interested in biosimilars have naturally been eagerly awaiting the next usual step in the process, the issuance of final guidances and perhaps the first …
By Kurt R. Karst – In a Complaint (and Motion for Temporary Restraining Order and Expedited Preliminary Injunction) lodged in the U.S. District Court for the District of Columbia, Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc. (collectively “Teva”) allege that FDA’s May 2, 2014 denial …
By Anne K. Walsh & Kurt R. Karst – Earlier this week, Hyman, Phelps & McNamara, P.C. submitted a Citizen Petition to FDA on behalf of a client requesting that the Agency determine that Ranbaxy Laboratories, Ltd. (“Ranbaxy”) has forfeited or is not eligible for first-to-file …
