• Regulatory NewsRegulatory News

    CDRH Drafts New Framework to Create a Pediatric Device Safety Network

    A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...
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    Cybersecurity: CDRH to Update 2014 Premarket Policies

    Ahead of a new US Food and Drug Administration (FDA) draft guidance set to be released in FY 2019, lead of cybersecurity initiatives at the Center for Devices and Radiological Health (CDRH) Suzanne Schwartz previewed policy changes at RAPS’ 2018 Convergence.   The US healthcare industry has become a target for cyberattacks over the past few years and this has been partly linked to inadequate device designs, which must undergo regulatory premarket reviews to mitigate cy...
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    CDRH Looks to Expand Case for Quality Program

    With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end. CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institut...
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    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
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    KPMG/RAPS Survey Digs in to Device Makers' EU MDR Preparedness

    A new report from KPMG and RAPS sheds light on how prepared medical device companies are for the new European medical device regulation (MDR) as the 2020 compliance deadline approaches.   The report, which is based on a survey conducted in June 2018, received responses from more than 200 regulatory and quality professionals at medical device companies worldwide. It was released during RAPS' 2018 Convergence in Vancouver, Canada.    One of the key findings relates t...
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    Brazil’s ANVISA to Eliminate Backlog of Applications

    Brazilian drug regulator ANVISA said Wednesday at RAPS’ Regulatory Convergence that it would eliminate a backlog of new and generic drug applications by January 2019. The elimination of the backlog will free the regulator up for new projects, and comes as more than 800 applications were backlogged as of January 2017, Raphael Sanches Pereira, general manager at ANVISA said. Pereira also said that ANVISA by the end of this year will make a proposal to rely on Certif...
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    Reorganization of OND to Support New Drug Review Modernization, Woodcock Says

    The reorganization of the US Food and Drug Administration’s (FDA) Office of New Drugs will help support the modernization of new drug reviews, Janet Woodcock, head of FDA’s Center for Drug Evaluation and Research told attendees of RAPS’ Regulatory Convergence on Thursday. She said the plan is to begin restructuring the premarket safety review process and then move into the investigational new drug (IND) application process. By frontloading a lot of the activities, th...
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    Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR

    Findings from a recent survey of notified bodies (NB) in Europe suggests the audits needed for compliance with the new medical device regulation (MDR) will not be completed in time, TÜV SÜD Product Service GmbH VP Bassil Akra said Wednesday at 2018 Regulatory Convergence.   The survey conducted by Team-NB was designed to assess the impact of a contentious issue with regard to the ongoing transition to the new EU MDR and in vitro diagnostic regulation (IVDR). This r...
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    RAPS Releases Results of Compensation Survey of Regulatory Professionals

    RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved. RAPS’ 2018 Global Compensation & Scope of Practice Report for the Regulatory Profession aggregates salary data for more than 2,300 respondents from 64 countries and breaks down median and averag...
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    RAPS Introduces Pharmaceutical- and Medical Device-Focused Regulatory Affairs Certifications (RACs)

    RAPS today announced two new Regulatory Affairs Certifications (RACs) will become available beginning with the next RAC exam period in spring 2019. Exam applications are now being accepted. The two new exams and associated credentials are called the RAC (Drugs) and RAC (Devices). They join the four previously established, regional exams: US, EU, Canada and Global. The RAC is the only post-academic professional credential for the healthcare product regulatory field....
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    John Lim, Justina Molzon, Barbara Schneeman and Mike Ward to Receive RAPS’ Highest Honor

    RAPS has announced the recipients of its 2018 Founder’s Award. They are: John Lim, MD, executive director, Center of Regulatory Excellence, Singapore; Justina Molzon, JD, former associate center director for international programs, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA); Barbara Schneeman, PhD, former director, Office of Nutrition, Labeling and Dietary Supplements, FDA; and Mike Ward, coordinator, Regulatory System Strengthen...
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    RAPS to Honor Lena Cordie, Alan McEmber for Outstanding Community Leadership

    RAPS has announced the recipients of its 2018 Community Leadership Award. They are: Lena Cordie, president, Qualitas Professional Services, and Alan McEmber, MS, RAC, head, therapeutic area regulatory strategy, Shire. The Community Leadership Award recognizes RAPS members who have helped build thriving local networks, supported fellow regulatory professionals and acted as RAPS ambassadors. Cordie and McEmber will be honored and receive their awards next week during RAP...