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    CDRH, MDIC Look to Global Application for NEST

    With the first version of the National Evaluation System for health Technology (NEST) set to open for business by the end of 2019, the shared vision among management at the US Food and Drug Administration (FDA) has expanded to a global scope.   “Regulators are always looking for scientific proof that your device does what you say it's going to do and is as safe as you say it is,” interim chair of the NEST Coordinating Center (NESTcc) Michelle McMurry-Heath told Focus ...
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    FDA Finalizes Guidance on Benefit-Risk Factors for 510(k)s

    The US Food and Drug Administration (FDA) on Monday finalized guidance on evaluating the benefit-risk profile of medical devices submitted under the 510(k) pathway that have the same indication as their predicate devices but have different technological characteristics and benefit-risk profiles.   FDA says the guidance is meant to address situations when a new device carries an increase in risk accompanied by an increased or equivalent benefit or when a new device carr...
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    Phase 3 Trial Costs Estimated at $19M, Study Finds

    The cost of a Phase III clinical trial ranges widely, though a new study pegs the median cost of 138 clinical trials in 2015 and 2016 at $19 million. “This study identified more than 100-fold differences in the costs of pivotal trials that the FDA required to provide substantial evidence of benefit, with a central cluster of trials with estimated costs of $12.2 million to $33.1 million,” Thomas Moore of the Institute for Safe Medication Practices and others from Johns H...
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    Researchers Point to R&D Treaty to Spur New Infectious Disease Treatments

    As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper suggest forming a research and development treaty. The “most far-reaching” policy tool “may be a research and development treaty, which would provide a focal point for future global coordination, provide a long-term commitment to funding, and build on what has been learned from existing approaches...
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    Brexit-Related Medicine Supply Disruptions: EMA Revises List

    The European Medicines Agency (EMA) on Monday announced that the number of centrally authorized medicines (CAPs) for which there are concerns of Brexit-related supply disruptions has declined from 108 to 39 (25 human medicines and 14 veterinary medicines). “This revision results from EMA’s follow-up activities with the marketing authorisation holders [MAHs] of the 108 medicines that were identified as deemed to be at risk of supply shortages” once the UK leaves the EU o...
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    EMA Extends Valsartan Review to Include Four More Active Substances

    The European Medicines Agency (EMA) announced Friday it has extended its review of two impurities classified as probable human carcinogens from its initial valsartan focus to include medicines containing four other “sartans.”   The move to include candesartan, irbesartan, losartan and olmesartan in the ongoing review was prompted by the detection of “very low levels of N-nitrosodiethylamine (NDEA)” in the losartan products manufactured by Hetero Labs in India, EMA sai...
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    DITTA Calls on FDA, Health Canada to Take Up Proposed IMDRF Work on Cybersecurity

    A new work item on cybersecurity was proposed at the International Medical Device Regulators Forum (IMDRF) management committee hearing this week in Beijing, China by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA).   Pending the outcome meeting statement to be released by IMDRF chair China Food and Drug Administration, DITTA chair Patrick Hope told Focus that the proposed new work item is centered on three areas of cybersec...
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    CHMP Backs 13 New Medicines, Maintains Negative Opinion of Sarepta’s Exondys

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended thirteen new medicines for EU approval and reaffirmed its negative opinion of Sarepta Therapeutics’ Duchenne muscular dystrophy drug Exondys (eteplirsen).   Among the thirteen drugs recommended for approval are three orphan drugs, three Neulasta (pegfilgrastim) biosimilars, two anti-cancer drugs and a new antibiotic.   The three orphan medicines include...
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    FTC Charges First Marketer of Intravenous Products

    The Federal Trade Commission (FTC) has, for the first time, charged a marketer and seller of intravenously injected therapy products, known as iV Cocktails, with making a range of “deceptive and unsupported health claims” about their ability to treat serious diseases. The proposed FTC order prevents the company, which operates clinics in Texas and Colorado, and its owner from making such claims unless they can be supported by competent and reliable scientific evidence. ...
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    FDA Releases ADMA Biologics Form 483 as Company Announces VAI Status

    The US Food and Drug Administration (FDA) this week unveiled a Form 483 from April for ADMA Biologics, a company that previously received a complete response letter related to manufacturing deficiencies. Earlier this month and prior to the 483’s release, however, ADMA said FDA’s inspection database classification website has been updated and “confirms ADMA’s compliance status has improved to Voluntary Action Indicated (VAI).” FDA explains the VAI designation as: “O...
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    Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance

    Drugmakers GlaxoSmithKline (GSK), Sanofi and Perrigo are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on field alert report (FAR) submissions. The draft guidance, released for comment in July , describes FDA’s current thinking on submitting FARs for new drug applications (NDAs) and abbreviated new drug applications (ANDAs). In the guidance, FDA calls on applicants to submit a FAR within three working days ...
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    Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

    Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA has released a third Form 483 for the company. Following inspections in July and August, FDA issued the 483 with 11 observations, with specific issues raised about the firm’s quality unit. “The system for managing quality to ensure confidence that the API [active pharmac...