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    Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

    Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel tha...
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    ICH releases revised Q9 guideline to improve risk assessments

    The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more scientific and robust applications of quality risk management principles (QRM)” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH business plan .   The ICH Q9(R1) guideline was published on the European Me...
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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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    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...
  • Report: Increase in Due Diligence Actions Being Driven by Global Legal Trends

    A new report published by PricewaterhouseCoopers (PwC) claims an increase in due diligence activities by regulatory professionals is being driven by a huge increase in global legislation aimed at clamping down on corruption and other shady practices. "Regulators around the world have made it clear that a lack of knowledge about a corrupt act is not a defense; that individual executives will be held criminally liable for the acts of intermediaries; and that hefty fines an...