• Regulatory NewsRegulatory News

    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
  • RF Quarterly

    The history of clinical trial disclosure

    The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...
  • Regulatory NewsRegulatory News

    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
  • Feature ArticlesFeature Articles

    Artificial intelligence in regulatory practice

    This article will examine ways in which the regulatory profession can draw artificial intelligence (AI) to navigate the complexities and fluidity of the global regulatory landscape. Keywords – artificial intelligence, big data, machine learning, SaMD   Introduction Many of the processes within the regulatory landscape entail gathering data, tabulating spreadsheets, collating documents for regulatory submissions, and reviewing dossiers to ensure their quality is c...
  • Regulatory NewsRegulatory News

    Industry cites outdated standards as flaw in FDA’s real-world data draft guidance

    The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data not currently reflected in the Data Standards Catalogue, according to industry comments on the agency’s draft guidance.   Overall, comments from industry generally supported the principles in FDA’s draft guidance on data standards for drug and biological products submissions containing RWD (RELATED: FDA drafts data sta...
  • Regulatory NewsRegulatory News

    FDA issues draft guidance on study designs using real-world data

    The US Food and Drug Administration (FDA) has issued draft guidance to industry on how real-world data (RWD) could be used in clinical trials and how it could be incorporated into the design of non-interventional studies.   The draft guidance , released Thursday, outlines the applicability of FDA’s investigational new drug application (IND) regulations to clinical study designs that use RWD and clarifies the agency’s expectations on new drug applications (NDAs) or bio...
  • Regulatory NewsRegulatory News

    Study: RWD not ready for postapproval prime time

    For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional postapproval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study.   “The findings of this cross-sectional study suggest that none of the 50 [Food and Drug...
  • Feature ArticlesFeature Articles

    October’s Regulatory Focus: Linguistic review, advanced therapies in Asia-Pacific, and more

    Feature articles during October included an in-depth look at the linguistic review process in Europe and  reviews of the regulatory pathways for herbal medicinal products, medical devices, and supplements in the EU and for advanced therapies in the Asian-Pacific region. Also included was an article on the challenges of data integrity remediation in cGMP facilities.   Linguistic review and herbal product regulation The linguistic review process for centrally authori...
  • Feature ArticlesFeature Articles

    Data integrity remediation and cGMP facilities

    Data integrity remediation is a critical activity performed by analytical laboratories, quality control laboratories, and manufacturing plants to comply with good manufacturing practice (GMP) and data integrity requirements. There are various challenges during this activity, and current GMP (cGMP) facilities struggle to comply due to technical limitations and resource constraints. This article examines the data integrity remediation challenges faced by cGMP facilities and ...
  • Regulatory NewsRegulatory News

    Improving transparency of regulatory data at EMA, Health Canada, FDA

    Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...
  • RF Quarterly

    Data integrity and compliance with GxP: A pragmatic approach

    Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...
  • Feature ArticlesFeature Articles

    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...