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    FDA Finalizes Two Medical Device Guidelines

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidance documents: one on factors to consider when making benefit-risk determinations for premarket approval (PMA) and de novo classifications, and one on the concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI) that may inform FDA's benefit-risk determinations. The 62-page guidance on benefit-risk determinations, finalized more th...
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    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...
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    Ethics and Risk Management: Lessons from the VW Defeat Device

    This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events. Biomedical professionals are constantly reminded of ethics and risk management in all roles in the field. The financial impact of an organization failure can be nearly limitless when regulatory and/or legal risks are not mitigated through the quality system. As a profession, it is clearly understood biomedical innovations ...
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    New Senate Bill Would Change the Way FDA Regulates Devices

    A new Senate bill introduced this week would, among other things, allow the US Food and Drug Administration (FDA) to no longer require premarket submissions for some low-risk Class I and II medical devices. The bill, which is sponsored by Sens. Amy Klobuchar (D-MN) and Pat Roberts (R-KS), and supported by industry group AdvaMed, would also: Require FDA to address within two months any changes proposed to an appropriate standard established by a nationally or internati...
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    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
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    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...
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    Advancing Regulatory Science: Research Success in a Public-Private Partnership

    This article discusses how a public-private partnership brought stakeholders together to advance regulatory science research in patient preference assessment. In May 2015, the Medical Device Innovation Consortium (MDIC) published a first-of-its-kind report, "A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology." 1 This "Framework" is not only a break-through publication in the...
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    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
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    FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration

    The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems. Background With the passage of the 2007 Food and Drug Administration Amendments Act , FDA was granted the authority to require manufacturers to develop REMS for new and approved products. These plans are intended to enable companies to better manage know...
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    FDA’s Approach to Regulating Fitness Trackers Wins Industry Praise

    Should "general wellness" products like weight management tools, fitness trackers or relaxation helpers be regulated as de facto medical devices? The US Food and Drug Administration (FDA) doesn't think so, much to the relief of manufacturers of general wellness products. Background In recent years, FDA has struggled to regulate new types of products which straddle the line between healthcare product (i.e. a medical device) and general consumer wellness (not regulated by...
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    BIO Calls for Increased Emphasis on Patient Perspectives by Biopharma, FDA

    Biopharmaceutical companies should seek out and incorporate the perspective of patients earlier on in the drug development process, a new white paper from the Biotechnology Industry Organization (BIO) argues. Background The call comes in the midst of a sustained shift by both companies and regulators to incorporate the views of patients into the regulatory process. Starting in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) , FDA has begu...
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    FDA Unveils New Website Improvements to Help Industry Keep Track of REMS

    The US Food and Drug Administration (FDA) is making it easier to find information about the controls that police the use of some of the most dangerous drugs approved for use in the US. Background Those controls, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007  Food and Drug Administration Amendments Act (FDAAA)  and are meant to ensure the safe use of potentially risky products that might otherwise not be approved for use. F...