• RF Quarterly

    Initiating clinical trials in China: What foreign medtech companies need to do

    This article discusses numerous recent changes in the regulation of clinical trials in China and proposes that Chinese clinical trials for medical device and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes. [Updated]*   China’s regulatory framework Most life sciences products, including medical devices and IVDs, sold in China are supervised by the National Medical Products Administration (NMPA).  The ...
  • Regulatory NewsRegulatory News

    Government and pharma search for post-pandemic silver linings

    Where will biopharmaceutical research head once the pandemic abates? This week, the Milken Institute assembled leaders from federal agencies, nonprofit organizations, and the pharmaceutical industry for an hour-long discussion to answer the question of whether there may be post-pandemic silver linings for biomedical innovation.   Though some things were done right, some things could have been done better, said Janet Woodcock, MD, acting commissioner of the US Food and ...
  • Regulatory NewsRegulatory News

    Trials without clinical sites offer chance for improved access, generalizability

    The COVID-19 pandemic has fueled the rise of clinical trials without clinical sites and opened the door to continuing these innovative models after the public health crisis has faded. While these trials offer the potential to expand access and the generalizability of results, there are also some limitations to conducting drug trials in this format.   In a special communication in  JAMA Internal Medicine , Steven R. Cummings, MD, director of the San Francisco Coordina...
  • Regulatory NewsRegulatory News

    FDA warns COVID trial sponsor for failing to submit IND

    The US Food and Drug Administration (FDA) last month warned a clinical trial sponsor for failing to submit an investigational new drug (IND) application for a study of a product to treat COVID-19.   In its warning letter to KDunn and Associates, P.A. dba HealthQuilt, FDA said it observed “objectionable conditions” during an August inspection related to a trial the company sponsored titled “An Open-Label Pilot Study to Assess the Efficacy and Safety of [redacted] in Sub...
  • Regulatory NewsRegulatory News

    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
  • Regulatory NewsRegulatory News

    FDA: Exclusion not necessary for EUA vaccine, therapeutic recipients

    In an update to its guidance on conducting clinical trials amid the COVID-19 pandemic, the US Food and Drug Administration (FDA) on Wednesday explained COVID-19 treatments and vaccines used under an emergency use authorization (EUA) are not considered investigational products for the purposes of clinical trial exclusion criteria.   The guidance, first issued in March 2020, has been updated several times throughout the pandemic to address questions raised by industry ab...
  • Regulatory NewsRegulatory News

    FDA finalizes certificates of confidentiality guidance

    The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy of clinical trial participants.   “By protecting researchers from being compelled to disclose identifiable, sensitive information about the research participants, CoCs help protect the identity of the research participants and achieve the objectives of the research,” FDA writes.   FDA explains that t...
  • Regulatory NewsRegulatory News

    FDA offers strategies to streamline schizophrenia drug trials

    Shortening the length of clinical trials and simplifying the symptom scale are two strategies that could help make schizophrenia drug trials less costly and more efficient, according to study findings from scientists at the U.S. Food and Drug Administration (FDA).   Schizophrenia drug developers face several obstacles when evaluating treatments, including high patient dropout rates in trials, modest treatment effects, high placebo response, and uncertainty about which ...
  • Regulatory NewsRegulatory News

    CONSORT-AI sets standards for reporting on artificial intelligence in trials

    A new consensus statement, dubbed the CONSORT-AI extension, lays out the rules of the road for clinical trial reports on interventions involving artificial intelligence (AI).   The statement, which was published in Nature Medicine and written by an international working group, includes 14 new items for researchers to routinely include in their manuscripts when reporting on AI interventions.   The statement calls on researchers who report on trials that include AI...
  • Regulatory NewsRegulatory News

    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...
  • Regulatory NewsRegulatory News

    EMA finalizes pediatric trial preparedness framework

    The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded,” according to EMA.   This framework’s releas...
  • Feature ArticlesFeature Articles

    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...