• Regulatory NewsRegulatory News

    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
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    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
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    After Weathering Scandals, UK Appoints New Medical Device Oversight Official

    The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has appointed a prominent academic figure, Dr. Peter Nightingale, to be the chair of its newly formed expert group on medical devices—a position intended to help UK regulators strengthen oversight of the UK's medical device sector. Background In 2014, an independent review of the UK’s MHRA concluded that the agency needs to bolster its oversight of medical devices and increase its engagement with the ...
  • UK Convenes Expert Panel to Assess New Regulatory Framework for Implants

    • 15 August 2012
    The UK's Department of Health (DOH) is preparing to launch an expert inquiry into ways to protect consumers from potentially dangerous cosmetic implants, just months after UK regulators concluded there was significant room for improvement. In a 15 August press release , DOH said a panel of experts led by Sir Bruce Keogh, the National Health Service's medical director, would examine the regulatory framework for cosmetic products in the UK, the information available to pa...
  • ICH Looking to Establish New Harmonized Guideline on Carcinogenicity Testing

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 14 May it has established a concept paper and business paper for a new expert working group (EWG) aiming to develop guidance on rodent carcinogenicity testing. "The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clar...
  • Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

    Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases. The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 ( EXPERRT Act ) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen...
  • IOM Releases Report on Biomarkers and Surrogate Endpoints

    The Institute of Medicine (IOM) released a workshop summary on 14 February that explores the evaluation process for biomarkers used to detect surrogate endpoints in chronic diseases. An initial report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease , was requested by the US Food and Drug Administration (FDA), and released by IOM in May 2010. Biomarkers are "indicators of normal biological processes, pathogenic processes or pharmacologic response...