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    Ambiguity from FDA Stunts Growth in the US, While Innovation Flourishes in Europe

    Editor's note: RAPS is a neutral, non-lobbying organization. The views expressed in this Perspectives piece by Chris Velis, CEO and chairman of MedCap Advisors, are those of the author. We hope this article will stimulate conversation, and we invite you to discuss it in the Regulatory Open Forum on Regulatory Exchange , our private social media community for RAPS members. Current State of Affairs Inconsistency and ambiguity in the US Food and Drug Administration's (F...
  • C-Path Obtains EMA, FDA Approval for Tool to Expedite Development of Alzheimer's Treatments

    The Critical Path Institute (C-Path), a public-private hybrid organization supported directly by the US Food and Drug Administration (FDA), has announced a "big step forward for Alzheimer's disease therapy development," saying that it has obtained the support of FDA and the European Medicines Agency (EMA) to launch a new disease simulation tool intended to improve clinical trial design for investigating Alzheimer's treatments. C-Path, which was founded in 2005 under FDA'...
  • Chinese Provinces Get Class III Device and IVD Inspection and Approval Authority

    The China Food and Drug Administration (CFDA) has issued a notice regarding adjustments to the duties undertaken by provincial food and drug supervision and management departments, part of an effort to implement the State Council institutional reform and functional transformation plan to further the reform of administrative evaluation and approval of medical devices. The notice points out that as of 1 October 2013, the provincial Food and Drug Administration department...
  • New Legislation Seeks Creation of Provisional Approval Pathway for New Drugs

    Three US legislators have moved to introduce legislation they say would accelerate US Food and Drug Administration (FDA) approvals while giving patients the option to obtain therapies outside of clinical trials. Background US regulators now have a variety of tools at their disposal with which to accelerate the approval of pharmaceutical products. The most prominent of those tools are geared toward patients with serious diseases, and include fast track designation, acc...
  • New Brain Hemorrhage Treatment Intended as Improvement Over Existing Risky One

    Regulators with the US Food and Drug Administration (FDA) announced on Tuesday the approval of Arbor Pharmaceuticals' drug Nymalize (nimodipine), a drug intended to treat brain hemorrhaging in patients. FDA's 14 May 2013 statement explained that the agency has received reports over the years regarding "serious and sometimes fatal consequences" associated with using intravenous (IV) injections of nimodipine capsules, including death, cardiac arrest and severe decreases in...
  • GSK's new COPD Therapy Wins FDA Approval

    The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's chronic obstructive pulmonary disorder (COPD) drug Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), just weeks after an FDA advisory council gave the drug its stamp of approval. The drug is a combination of the inhaled corticosteroid fluticasone furoate and a long-acting bronchodilator, vilanterol. In a statement, FDA said the drug, which had undergone clinical testing in nearl...
  • Ultra-Rare Disease gets New FDA-Approved Therapy Intended to Make Treatment more Tolerable

    US regulators have approved a new product intended to treat an extremely rare disease known as nephropathic cystinosis, a disease that affects fewer than 3,000 patients worldwide and causes a buildup of cysteine in the body that can be fatal if not treated early in life. The drug, Procysbi, treats the condition by providing a delayed-release formulation that delivers cysteamine to patients in a new method. The drug's sponsor, Raptor Pharmaceuticals, explains on its websi...
  • Warfarin Patients Stand to Benefit from New FDA-Approved Drug Kcentra, Company Says

    The US Food and Drug Administration (FDA) has approved Kcentra (prothrombin complex concentrate), a new biological treatment indicated for the urgent reversal of vitamin K antagonist (VKA), a class of anticoagulants that can lead to major bleeding events and death. Prior to Kcentra's 29 April 2013 approval by FDA's Center for Biologics Evaluation and Research (CBER), the only FDA-approved method to reverse VKA was through an infusion of blood plasma, regulators said. Th...
  • In Wake of Broader Concerns, India's DCGI Creates Panel to Investigate Drug and Trials Approvals

    India's Drugs Controller General (DGC), in an order dated 26 March 2013 , has convened a special committee to investigate allegations that the Central Drugs Standard Control Organization (CDSCO) did not adhere to "scientific requirements and … regulatory compliance" in four cases involving the approval of drugs and clinical trials.  The order was issued at the request of the Parliamentary Standing Committee with oversight authority for the CDSCO.  Th...
  • New CF Therapy Approved, Once Again Based on Help From Patient Group

    For the second time in as many years, the US Food and Drug Administration (FDA) has approved a new product intended to treat patients with cystic fibrosis (CF), a rare disease that affects fewer than 30,000 patients in the US. Background The new product, known as the TOBI Podhaler (tobramycin inhalation powder) is a combination product that contains an antibiotic powder, tobramycin, which is used to treat CF patients with Pdeudomonas auruginosa, a type of bacteria that ...
  • US Regulators Approve Lymph Node Mapping Diagnostic Imaging Agent

    US regulators have approved a new radioactive diagnostic imaging agent manufactured by Navidea Biopharmaceuticals that is intended to assist in the location of lymph nodes in patients with breast cancer or melanoma. The approval, FDA's sixth of the 2013 calendar year, is the first new drug used for lymph node mapping to be approved in more than 30 years, FDA explained. At least two other products are approved for the condition, including sulfur colloid and isosulfan blue...
  • US Regulators Approve Fourth Breast Implant Product, Call for Extensive Safety Testing

    If there's one device that global medical device regulators have spent much of the last year worrying about, it's breast implants. But now, and with a nod to safety critics, US regulators have approved a fourth breast implant product for marketing in the US. Background Late in 2011, French regulators began to receive reports that breast implants manufactured by Poly Implant Prothese (PIP) were failing at an alarmingly high rate. The ensuing fallout was in many ways th...