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    Month: November 2012

    • ASBM Says Distinct USAN Names for Biosimilars are NeededNovember 30th, 2012

      By Kurt R. Karst –       The Alliance for Safe Biologic Medicines (“ASBM”), a self-described “organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of …

    • In a FSMA First, FDA Suspends a Food Facility’s RegistrationNovember 29th, 2012

      By Ricardo Carvajal & John R. Fleder – On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella.  Until the …

    • Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing ConductNovember 27th, 2012

      By Bill Koustas & Alan Kirschenbaum – In July, we reported that Massachusetts had amended its prescription drug and device marketing law to (among other things) allow pharmaceutical and medical device companies to provide “modest meals and refreshments” as part of an informational presentation to …

    • Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR PatentNovember 27th, 2012

      By Kurt R. Karst – In a recent Complaint for Declaratory Judgment filed in the U.S. District Court for the Northern District of Illinois (Eastern Division), Apotex Inc. (“Apotex”) is attempting to trigger 180-day exclusivity for generic versions of the hypertension drug BENICAR (olmesartan medoxomil) Tablets, …

    • “Product Hopping” Antitrust Lawsuit Takes on a Heightened Profile with Proposed FTC Amicus BriefNovember 25th, 2012

      By Kurt R. Karst –       A Complaint filed earlier this year by Mylan Pharmaceuticals Inc. (“Mylan”) in the U.S. District Court for the Eastern District of Pennsylvania alleging that Warner Chilcott and Mayne violated Sections 1 and 2 of the Sherman Act by engaged in …

    • No Preemption of California Class Action Targeting Nutrient Content ClaimsNovember 22nd, 2012

      By Riëtte van Laack – In April 2012, a California consumer filed a class action lawsuit against The Hershey Company alleging that Defendant’s Special Dark Chocolate Bars, Special Dark Kisses, Special Dark Cocoa and Cocoa were misbranded because they carried impermissible nutrient content claims, including nutrient …

    • FDA Seeks Comments on Custom DevicesNovember 20th, 2012

      By Jennifer D. Newberger – Section 520(b) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") exempts “custom devices” from the performance standards or premarket approval ("PMA") requirements of sections 514 or 515 if certain criteria are met.  The Food and Drug Administration Safety and …

    • Robert Dormer to Speak at ACI Orphan Drugs and Rare Diseases ConferenceNovember 20th, 2012

      Hyman, Phelps & McNamara’s Robert A. Dormer will be speaking at the American Conference Institute’s upcoming conference, “Orphan Drugs and Rare Diseases – Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.”  The conference will take place on November 28th and 29th …

    • CSPI Jacks Up Scrutiny of Caffeination and FortificationNovember 19th, 2012

      By Ricardo Carvajal – The Center for Science in the Public Interest (“CSPI”) is taking on caffeination and fortification of foods with renewed vigor.  In a letter to FDA/CFSAN’s Office of Compliance, CSPI alleges that certain foods to which caffeine is added “appear to violate [FDA’s] …

    • FDA Amends UDI Proposed Rule to Comply with FDASIA RequirementsNovember 19th, 2012

      By Jennifer D. Newberger – FDA is amending its proposed rule to establish a unique device identification (“UDI”) system, published on July 10, 2012 (see our previous post here), to meet the requirements of section 614 of the Food and Drug Administration Safety and Innovation Act …

    • FDA and California Board of Pharmacy Talk Pedigree at Annual HDMA Track and Trace ConferenceNovember 18th, 2012

      By Jess Ritsick & Bill Koustas – The Healthcare Distribution Management Association (“HDMA”) held its annual Track and Trace Technology Seminar on November 12 – 14, 2012, designed to address drug pedigree and track and trace requirements being developed in the United States and to …

    • Cumberland Sues FDA After the Agency Denies Citizen Petition and Approves Generic ACETADOTENovember 16th, 2012

      By Kurt R. Karst –       Earlier this week, Cumberland Pharmaceuticals Inc. (“Cumberland”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s November 7, 2012 denial of a Citizen Petition (Docket No. FDA-2012-P-0507) and approval of InnoPharma, Inc.’s (“InnoPharma’s”) ANDA …

    • A Three-peat: U.S. News & World Report Ranks HP&M as Top Tier FDA Law FirmNovember 15th, 2012

      For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks over at U.S. News & World Report, who once again teamed up with Best Lawyers …

    • HP&M’s Dave Clissold to Speak at Management Forum Conference on Orphan Drug, Regulatory Strategy Matters, and MoreNovember 15th, 2012

      Hyman, Phelps & McNamara, P.C. is pleased to announce that David B. Clissold will be speaking at an upcoming Management Forum conference on myriad topics, including orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products.  The conference, titled “EU and US Regulatory Issues for …

    • With Briefing Over, Post-Mensing Generic Drug Preemption Appeal Awaits Word From the Supreme CourtNovember 14th, 2012

      By Kurt R. Karst –       Back in August, we posted on a Petition for Writ of Certiorari filed by Mutual Pharmaceutical Company, Inc. (“Mutual”) appealing a May 2, 2012 decision from the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical …

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