• RF Quarterly

    Clinical trials, good clinical practice, regulations, and compliance

    This article provides an overview of the international and national guidelines associated with clinical trials. The authors highlight the importance of multiregional clinical trials and outline the principles of good clinical practice (GCP) and regulatory compliance.   Introduction Clinical trials are essential components of pharmaceutical research and development. A clinical development program’s broad aim is to treat a specific indication in a certain population to...
  • RF Quarterly

    Planning for a clinical trial application

    In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true impact of an investigational drug. Global clinical trials offer key advantages to patients and industry, but smaller companies may be hesitant to participate in global trials, wondering if the inevitable challenges outweigh the benefits. The key considerations in designing a ...
  • RF Quarterly

    Modernizing clinical trial regulations in Canada

    This article provides an overview of Health Canada’s plans to modernize its clinical trials regulations and enhance health care agility in the regulatory framework for its health care products by making regulations more flexible and adaptive to innovation. The author discusses how clinical trials in several health care product lines can be modernized and looks at how lessons learned from the COVID-19 pandemic experience can help set up a more flexible regulatory framework ...
  • RF Quarterly

    The Canadian application process and alternate pathway for COVID-19‒related trials

    This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations for Clinical Trials Involving Human Subjects in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range of clinical trial submission requirements and communication with Health Canada’s relevan...
  • 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 guidance on complex innovative trials designs

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance for sponsors on interacting with the agency on complex innovative trial designs (CID) for drugs and biologics.   The nine-page final guidance comes just over a year after the draft version was released for comment and two years after the agency launched its CID pilot program. (RELATED: FDA launches pilot program in support of complex trial designs for drugs and biologics , Regulatory Focus 2...
  • 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...