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  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • Regulatory NewsRegulatory News

    FDA updates on ASCA pilot, lists accredited test labs

    In an important step in the rollout of its accreditation scheme for conformity assessment (ASCA) pilot, the US Food and Drug Administration (FDA) this week published its initial list of accredited testing laboratories participating in the program.   The pilot, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV) program, is meant to increase “consistency, predictability and efficiency” during the premarket review of medica...
  • Feature ArticlesFeature Articles

    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
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    Comparison of pharmaceutical development drug regulatory pathways in the US and China

    The US has the largest pharmaceutical market in the world, as well as the highest expenditure in research and development (R&D). Right behind the US is China, in second place, as it steadily closes the gap, with increasing government investment in R&D and programs promoting the development of innovative medicines targeting the global market. To close that gap, there should be a strong R&D infrastructure, effective intellectual property protection, integration in global sta...
  • Regulatory NewsRegulatory News

    FDA finalizes ASCA pilot guidance as it gears up for launch

    The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.   The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible con...
  • Feature ArticlesFeature Articles

    Current Chinese NMPA clinical pathways for medical device registration

    This article presents the key highlights of the current clinical pathways for registering medical devices in China and discusses when the various clinical pathways should be used, based on the country's National Medical Products Administration (NMPA) regulations and guidances. Introduction The NMPA, 1 formerly known as the China Food and Drug Administration, is the Chinese agency responsible for regulating drugs and medical devices. In addition to the national NMPA, ...
  • Regulatory NewsRegulatory News

    Clinical Trials: FDA Releases Two Draft Guidances

    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial. The draft also advises sponsors on the types of information FDA needs to evaluate the results from trials with adaptive designs,...
  • Regulatory NewsRegulatory News

    FDA Details New Manufacturing Quality Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative. "CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety," FDA write...
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    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
  • Regulatory NewsRegulatory News

    CDRH to Launch 'Critical to Quality' Pilot Program

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will lead a pilot program to define characteristics of a device that are critical to product quality and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. The voluntary pilot, which will run from 29 September to 31 December 2018, invites firms submitting a Premarket Approval Application (PMA) to consider participating ...
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    Help Wanted: FDA Seeks Digital Health Entrepreneurs

    Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out, and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program. The idea is to embed these entrepreneurs for a minimum of three days per week on FDA’s White Oak campus to help analyze software business processes...
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    Professors Offer 3 Questions on FDA’s New Digital Health Framework

    The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs , who offer up three questions about the direction of the plan. First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not includ...