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  • Drug Development

    • New Legislation Seeks to Provide 5-Year NCE Exclusivity For Certain Combination DrugsAugust 5th, 2013

      By Kurt R. Karst –       Last Friday, Representative Jason Chaffetz (R-UT) introduced H.R. 2985, the Combination Drug Development Incentive Act of 2013.  The bill would amend the 5-year New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act that affect the submission and approval of …

    • Breakthrough Therapy Designation: Stakeholders Discuss the Program One Year LaterJuly 28th, 2013

      By James E. Valentine* & Alexander J. Varond – Since the breakthrough therapy designation came into existence a year ago, drug companies (and their investors) have been trying to figure out the value of the program.  The designation was initially proposed as a way to …

    • FDA Racks Up a Circuit Court Loss in Imported and Unapproved Thiopental Sodium Case; Will It Jeopardize FDA’s Drug Shortage Program?July 23rd, 2013

      By Kurt R. Karst –   In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision …

    • Fecal Microbiota Transplantation: FDA Announces Limited Enforcement DiscretionJuly 23rd, 2013

      By Alexander J. Varond – Undoubtedly, most microbes in humans are nonpathogenic, if not beneficial (a.k.a., “good bacteria”).  But, since at least the advent of the microscope, humans have shown great hostility toward pathogenic microbes, and relatively little regard for those that are nonpathogenic.  Antibiotics are …

    • FDA Provides Insight Into Breakthrough Therapy Designation, Consolidates Guidance for Expedited ProgramsJuly 1st, 2013

      By Alexander J. Varond – On June 25, FDA released a draft guidance entitled “Expedited Programs for Serious Conditions—Drugs and Biologics” and a related Manual of Policies and Procedures entitled “Review Designation Policy: Priority (P) and Standard (S).”   The draft guidance provides important insight into FDA’s …

    • Clinical Trial Disclosure – Keeping Ahead of the Wave; A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara, P.C.June 18th, 2013

      Transparency and data disclosure are this year’s hot issues for pharmaceutical companies. On the clinical trial front, Europe is leading the way, with initiatives from the European Medicines Agency and the European Parliament that will impact drug research and development world-wide. The proposed TEST Act …

    • Striding Towards Greater Access to Clinical Trials Data and ResultsJune 13th, 2013

      By James E. Valentine* & David B. Clissold – The pendulum has been swinging: the medical research community and public health advocates want access to clinical trials data used to support marketing applications of FDA-regulated medical products.  In 2007 that pendulum picked up momentum, with the …

    • House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013

      By Kurt R. Karst –       A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …

    • FDA Issues Final Orphan Drug RegulationsJune 12th, 2013

      By Michelle L. Butler – On June 12th, the final rule to amend FDA’s 1992 orphan drug regulations was published in the Federal Register.  78 Fed. Reg. 35117 (June 12, 2013).  This final rule, which largely finalizes the revisions as proposed in October 2011, will …

    • Generic and Innovator Drugs: The Next GenerationMay 7th, 2013

      By Kurt R. Karst –       Growing up in the late 1970s and 1980s I was a fan of several science fiction television series and movies: Doctor Who, Star Wars, and, of course, Star Trek.  I remember well the voyages of the starship Enterprise under the …

    • Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?February 20th, 2013

      By Kurt R. Karst –  A recent report from the National Institutes of Health (“NIH”) Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research leaves unanswered questions about the future utility of FDA’s so-called “Animal Efficacy Rule” for NIH-funded research intended …

    • OIG Report Calls Into Question Effectiveness of FDA’s REMS ProgramFebruary 18th, 2013

      By Alexander J. Varond – In response to FDA’s increasing reliance on Risk Evaluation and Mitigation Strategies (“REMS”) for the management of risks presented by certain drugs, the US Department of Health and Human Service’s Office of Inspector General (“OIG”) conducted an investigation into FDA’s …

    • The Orphan Drug Act: 30 Years and Still Going Strong!February 13th, 2013

      By Kurt R. Karst & Frank J. Sasinowski – The Orphan Drug Act (“ODA”), which President Ronald Reagan signed into law on January 4, 1983, turned 30 years old in January.  The milestone came just days after the death of actor Jack Klugman, who has been …

    • FDA Considering Alternative Approval PathwayJanuary 15th, 2013

      By Alexander J. Varond – FDA announced earlier this week that it will hold a public hearing to obtain input on a potential new pathway to expedite the development of drugs and biological products for serious or life-threatening conditions that would address an unmet medical …

    • Patient Power in Orphan DrugsJanuary 13th, 2013

      By Frank Sasinowski & William Koustas – FDASIA/PDUFA V elevates the role of patients in developing orphan therapies.  It mandates that FDA implement ways to bring patients' views into drug development and FDA’s regulatory review.  This is appropriate as it is often these patients that …