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    • PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use GroundsJanuary 31st, 2012

      By Kurt R. Karst –       The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request.  The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in …

    • CDRH Issues its Strategic Priorities for 2012January 29th, 2012

      By Jennifer D. Newberger – On Tuesday, January 24, FDA’s Center for Devices and Radiological Health (“CDRH”) released its strategic priorities for 2012:  (1) fully implement a total life cycle approach; (2) enhance communication and transparency; (3) strengthen the CDRH workforce and workplace; and (4) proactively …

    • Supreme Court Rules Federal Meat Inspection Act Preempts California’s Ban on Slaughter of Non-Ambulatory AnimalsJanuary 26th, 2012

      By Riëtte van Laack – On Monday, January 23, 2012, the U.S. Supreme Court ruled that a California state law prohibiting the slaughter, processing, and sale of any non-ambulatory animals is preempted by the Federal Meat Inspection Act (“FMIA”). As we previously reported, under California's Downed Animal …

    • GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and MisuseJanuary 25th, 2012

      By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) has issued a report focusing on federal agency efforts to educate prescribers and the public about prescription pain reliever abuse and misuse.  The report’s title, “Prescription Pain Reliever Abuse: Agencies have …

    • A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added TwistJanuary 24th, 2012

      By Kurt R. Karst –       In a recent Hatch-Waxman decision from the U.S. District Court for the Northern District of Illinois (Eastern Division), the court denied Plaintiffs’ Seattle Children’s Hospital, Novartis Vaccines and Diagnostics, Inc., and Novartis Pharmaceuticals Corporation (collectively “Novartis”) Motion to Dismiss the lawsuit …

    • Leap Year and Hatch-Waxman – An Unusual Conundrum Years in the MakingJanuary 23rd, 2012

      By Kurt R. Karst –       It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises.  Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …

    • Congressional Representatives Press FDA For Action on Third-Party AuditsJanuary 23rd, 2012

      By Ricardo Carvajal – In tandem with the release of a House Energy and Commerce Committee staff report on last year’s outbreak of Listeria monocytogenes in cantaloupe, members of that committee sent Commissioner Hamburg a letter calling for reforms in the conduct and oversight of third-party audits.  …

    • HP&M to Host Webinar on the FDA Appeals ProcessJanuary 19th, 2012

      Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes.  The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …

    • ACI’s FDA Boot Camp ConferenceJanuary 19th, 2012

      The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012.  A copy of the conference program can be obtained here.  Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …

    • FDA Sends User Fee Pacts to Congress; Proposed Generic Drug User Fee Statute Includes Some Unique ProvisionsJanuary 18th, 2012

      By Kurt R. Karst –       Last week, FDA Commissioner Margaret A. Hamburg, M.D. announced that the Agency sent to Congress packages for three user fee programs, including proposed statutory language for the fifth iteration of the Prescription Drug User Fee Act (“PDUFA V”), and two new …

    • Supreme Court To Decide When EPA and Perhaps Other Federal Agencies Can be Sued in Federal CourtJanuary 17th, 2012

      By JP Ellison – An important issue relating to when an action by an administrative agency can be challenged in court was argued before the Supreme Court last week.  The case involved administrative enforcement activities of the U.S. Environmental Protection Agency (“EPA”). The case, Sackett v. …

    • National Organic Program Proposes to Change Listing of Nutrients That Can be Added to Organic FoodJanuary 16th, 2012

      By Riëtte van Laack – USDA’s National Organic Program ("NOP") published a proposed rule that would amend the listing of vitamins and minerals in the National List of Allowed and Prohibited Substances (National List).  The National List identifies non-agricultural synthetic ingredients that may be used in …

    • FDA Denies Petition Seeking to Add Application Information to Drug LabelsJanuary 12th, 2012

      By Kurt R. Karst –       FDA recently denied a 2008 citizen petition (Docket No. FDA-2008-P-0291) requesting that the Agency amend its drug label regulations to require that product labels include the Orange Book-listed NDA number under which the product is approved.  According to the petition, “[i]ncreasingly, …

    • FDA Publishes Order Prohibiting the Extralabel Use of Antimicrobial Cephalosporins in Food-producing Major SpeciesJanuary 11th, 2012

      By Riëtte van Laack – The Animal Medicinal Drug Use Clarification Act of 1994 (“AMDUCA”) amended the FDC Act § 512(a) allowing veterinarians to prescribe extralabel use of certain approved animal and human drugs for animals.  (Extralabel use includes use in species not listed in the …

    • Senators Hatch and Harkin Request that FDA Withdraw Draft NDI GuidanceJanuary 10th, 2012

      By Riëtte van Laack – In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the …

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