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    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
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    Qualification of Drug Development Tools: FDA Updates Process

    Thanks to the 21st Century Cures Act , there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which include biomarkers, animal models and clinical outcome assessments. The US Food and Drug Administration (FDA) on Thursday said its goal is to transition from the legacy process to the new one, outlined in section 507 of the law, through a phased approach and the agency is currently developing a transition plan for existing projec...
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    Australia Considers Allowing the Marketing of Devices Approved Overseas

    Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...
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    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...
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    EU Health Tech Assessments: Majority Favor Continuing Beyond 2020

    A majority of respondents to a European Commission questionnaire, including pharmaceutical and medical device companies, says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020. The results, revealed in a EC report on Monday, found that almost all respondents (98%) consider it useful to compare whether new health technologies work better, equally well or worse than existing ones, as part of guidance to decision makers. Backg...
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    Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees

    Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy. “Some argue that individuals and their physicians should be free to make these decisions without relying on FDA to make determinations about marketing approval. However, the complexity of the data as well as examples ...
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    Asia Regulatory Roundup: TGA Consults on Accelerated Assessments for Devices (22 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Consultation on Accelerated Assessments of Medical Devices The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on a planned priority review pathway for medical devices. TGA is asking the industry to comment on its proposed criteria for awarding priority review status, the timeframes device developers on the pathway will face and its...
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    FDA, Health Canada Look to Implement Common Electronic Submission System

    As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators. The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaboratio...
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    FDA Revises Guidance on Special Protocol Assessments

    The draft guidance on the special protocol assessment (SPA) process is an update on guidance from 2002 and delves into the meetings between pharmaceutical or biotech sponsors and the US Food and Drug Administration (FDA) to discuss plans for clinical trials. Under the hopes that the SPA process will improve the quality of clinical trials, FDA has made significant changes from 2002 guidance, including: Clarification on which protocols are eligible for SPA; The addit...
  • TGA Offers Guidance on How Device Makers Can Reduce Assessment Fees by 70%

    Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled new guidance on the eligibility requirements for medical device and in vitro diagnostic (IVD) companies looking to reduce assessment fees by as much as 70%. The reduction in fees could save industry a significant amount of money as, according to the new fees published in July by TGA, conformity and audit assessment fees can range from about $4000 to more than $50,000, depending on the type of assessm...
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    Medical Device Audit Program Needs More Industry Involvement, Report Says

    A mid-pilot report on the international Medical Device Single Audit Program shows some progress, though work still needs to be done, particularly in terms of attracting industry participants before the expected operational launch in 2017, a recent report says. Background Back in January 2014, the International Medical Device Regulators Forum (IMDRF), the regulators-only successor group to the Global Harmonization Task Force, launched a two-year pilot program ...
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    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...