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    Month: November 2011

    • The Showdown Over AIA Section 37 Looms . . . .November 14th, 2011

      By Kurt R. Karst –    On November 15th, the U.S. Court of Appeals for the Federal Circuit will hear oral argument in Medicines Co. V. Kappos et al., Case No. 2010-1534, perhaps starting (or ending) another chapter in the saga over a Patent Term Extension (“PTE”) …

    • FDA Highlights Compliance Efforts Against Tobacco Product RetailersNovember 13th, 2011

      By Ricardo Carvajal – FDA issued a press release announcing the issuance of more than 1,200 warning letters to tobacco retailers alleged to have violated the agency’s Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.  Common alleged violations …

    • New Jersey District Court Says ANDA Approval Delay and Patent Uncertainty Are Insufficient to Support DJ Jurisdiction in Generic DETROL LA LitigationNovember 10th, 2011

      By Kurt R. Karst –       The U.S. District Court for the District of New Jersey recently granted a Motion to Dismiss filed by Pfizer, Inc. (“Pfizer”) in an action brought by Impax Laboratories, Inc. (“Impax”) in an apparent attempt to trigger a forfeiture of 180-day exclusivity …

    • Burton Proposes New Grandfathered Dietary Ingredient Date of January 1, 2007November 9th, 2011

      By Riëtte van Laack – Last week, Rep. Dan Burton (R-IN) introduced the “Dietary Supplement Protection Act of 2011.”  Referencing the exemplary safety record of dietary supplements, the bill proposes to amend section 413(d) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to significantly …

    • DOJ’s West Outlines Enforcement ConsiderationsNovember 8th, 2011

      By Anne K. Walsh – On November 2, 2011, DOJ’s Assistant Attorney General Tony West gave a keynote address at the Twelfth Annual Pharmaceutical Regulatory and Compliance Congress in Washington, DC.  During that speech, he touted DOJ’s “successes” against health care fraud achieved during the last …

    • Judge Leon Grants Preliminary Injunction- FDA’s Final Rule Requiring Graphic Warnings on Cigarette Packages Appears in JeopardyNovember 8th, 2011

      By David B. Clissold – As we previously reported, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a complaint against FDA in the U.S. District Court for the District …

    • U.S. News & World Report Ranks HP&M as Top Tier FDA Law Firm – Again!November 8th, 2011

      For the second year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of FDA Law (both nationally and in Washington DC) by the folks over at U.S. News & World Report, who teamed …

    • Will the Hatch-Waxman Lock be Sprung in 2012?November 7th, 2011

      By Kurt R. Karst –       For a few weeks now we’ve been hearing rumors that once the ball gets rolling in Congress with legislation to reauthorize the various user fee statutes (e.g., the  Prescription Drug User Fee Act and the Medical Device User Fee and Modernization …

    • HP&M Director to Present at FDLI Enforcement, Litigation and Compliance ConferenceNovember 7th, 2011

      The Food and Drug Law Institute’s (“FLDI”) annual Enforcement, Litigation and Compliance Conference is being held in Washington, DC on December 6-7, 2011.  Hyman, Phelps & McNamara, P.C. Director John R. Fleder is speaking at the conference.  As a result, we were able to secure …

    • FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather ClaimNovember 7th, 2011

      By Kurt R. Karst –       In a decision handed down late last week by the U.S. Court of Appeals for the Tenth Circuit, a three-judge panel affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss …

    • New Citizen Petition Asks FDA to Revoke Notice of FSMA User FeesNovember 4th, 2011

      By Susan J. Matthees – The American Council of Independent Laboratories (“ACIL”), the Association of Food Industries, and the Cheese Importers Association of America, Inc. recently petitioned FDA to revoke or partially revoke its Federal Register notice announcing Food Safety Modernization Act (“FSMA”) user fees amounts …

    • FDA Issues Report on Medical Device QualityNovember 4th, 2011

      By Jennifer D. Newberger – On October 31, 2011, FDA issued a report titled “Understanding Barriers to Medical Device Quality.”  The report results from an initiative launched by the Center for Devices and Radiological Health (“CDRH”) “to assess and understand gaps in medical device quality.”  The …

    • IOM Recommends a Single, Standard FOP Symbol System for FoodsNovember 3rd, 2011

      By Cassandra A. Soltis – The Institute of Medicine (“IOM”) recently issued its Phase II report on consumer use and understanding of front-of-package (“FOP”) labeling systems for foods, recommending that both the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) “consider …

    • Executive Order Aims to Cure Drug ShortagesNovember 2nd, 2011

      By Jennifer M. Thomas – President Obama issued an Executive Order earlier this week to address the growing issue of critical drug shortages – the first Executive Order to directly affect FDA operations since 1985.   In a coordinated move, FDA also released its report: "A Review …

    • Burr Amendment to Senate FDA Approps Bill Seeks FDA Approval Time TransparencyNovember 2nd, 2011

      By Kurt R. Karst –       Earlier this week, the U.S. Senate passed, by a 69-30 vote, H.R. 2112, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, as part of an omnibus package of three spending measures.  The House and Senate …

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