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    FDA Reveals Vision for the Transition to ISO 13485

    An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.   “I don’t mean to disappoint,” said William Maisel, chief medical officer at FDA’s Center for Devices and Radiological Health (CDRH). The plans to blend together certain provisions of  21 CFR Part 820 with ISO 13485 through new rulemaking have be...
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    Compounding: FDA Revises Insanitary Conditions Guidance, Finalizes Guidance on Radiopharmaceuticals

    The US Food and Drug Administration (FDA) on Tuesday issued a revised draft guidance on insanitary conditions at compounding facilities and two final guidances on compounding and repackaging radiopharmaceuticals as it works to ramp up enforcement of compounders and outsourcing facilities.   In recent years, FDA has updated its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least ...
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    Mandatory Reporting of Drug Shortages to Begin in Australia in 2019

    Beginning 1 January 2019, drugmakers will be required to report drug shortages in Australia, the country's Therapeutic Goods Administration (TGA) announced Tuesday. “Medicine shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective,” TGA said, noting that many critical shortages are not currently reported, meaning such information cannot be shared with consumers and health professionals, whi...
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    UK to Allow Electronic Consent Forms for Trials

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it will allow clinical trials of investigational medical products to use electronic signatures when obtaining consent from a patient to participate in a trial. The announcement comes as electronic ways to document informed consent, known as eConsent, are increasingly being adopted by sponsors and researchers either to supplement a paper-based consent design or, where appropriate, to repla...
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    FDA Warns Indian Drugmaker for CGMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Nandore, India-based Wilson Medicine for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Following an inspection from 26 February to 1 March, FDA investigators found the company not only did not demonstrate that its manufacturing processes are reproducible and controlled to consistently yield drugs of uniform character and...
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    New Patent Database to Help Governments Procure Medicines

    A new online tool could help government procurement agencies better understand the global patent status of medicines, the World Intellectual Property Organization (WIPO) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) announced Tuesday. WIPO is hosting the database, known as Pat-INFORMED, which went live Tuesday, and providing the resources to ensure its continued development, while IFPMA is working with 20 biopharma companies t...
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    Asia Regulatory Roundup: India Creates Compensation Application Form for People Affected by J&J Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Pushes Ahead With Efficacy Claimer Labels Despite Mixed Response   Australia’s Therapeutic Goods Administration (TGA) is going ahead with plans to allow the addition of an efficacy claim to the labels of certain nonprescription products. TGA committed to implementing the idea despite it receiving a frosty reception from producers of over-the-counter (OTC) medicin...
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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...