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  • Feature ArticlesFeature Articles

    A military-civilian perspective on real-world evidence to support regulatory decision making

    This article summarizes the framework promoting the collection and analysis of real-world data (RWD) in the healthcare system. The authors emphasize how the US Military Health System (MHS) used RWD during the Iraq and Afghanistan Wars to achieve historic rates of survival and describe a new era of collaboration between the US Department of Defense (DoD) and the US Food and Drug Administration (FDA). The article reviews the FDA evidentiary standards for medical product appr...
  • Regulatory NewsRegulatory News

    RWE to Supplement RCTs: FDA Projects Continue

    The US Food and Drug Administration (FDA) has been working with several different data and research companies to further its understanding of how real-world data (RWD) and real-world evidence (RWE) can help to inform its regulatory decision making. One such company that has signed an RWE research collaboration with FDA is COTA, Inc., which is working on a project related to replicating a breast cancer study. Andrew Norden, chief medical officer of COTA, told Focus ...
  • Regulatory NewsRegulatory News

    When Can RWE Translate Into Credible Evidence? EMA Officials Discuss

    Real-world evidence (RWE) may provide an opportunity to learn more about a drug’s benefits and risks, but officials from the European Medicines Agency (EMA) said in an article published Tuesday in Clinical Pharmacology & Therapeutics that there will need to be adequate statistical methods to extract, analyze and interpret RWE before they can translate into credible evidence. In order to ensure that any new analytical methods are acceptable for regulators, the EMA auth...
  • Regulatory NewsRegulatory News

    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...
  • Regulatory NewsRegulatory News

    FDA’s OCE Taps Syapse for Research on RWE

    San Francisco-based data company Syapse said Wednesday that it has signed a multi-year research collaboration agreement with the US Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) to work on using real-world evidence (RWE) to support regulatory decision making. Syapse and OCE will work with EHRs, labs and registries, among other data sources, to characterize the regulatory suitability of RWE derived from multiple sources. They will also work tog...
  • Regulatory NewsRegulatory News

    FDA’s No. 2 on RWE, Hype and Speeding Drug Development

    Just before PhRMA’s Innovation Day came to a close on Thursday, Novartis CEO Vas Narasimhan sat down with the US Food and Drug Administration’s (FDA) Principal Deputy Commissioner Amy Abernethy to discuss the rise of real-world evidence (RWE), what the technology and biopharma industries are over-hyping and why it’s so difficult to speed up drug development. Abernethy came to FDA less than a year ago from Roche’s Flatiron Health, which is at the forefront of the real-wo...
  • Regulatory NewsRegulatory News

    FDA Discusses RWD, RWE With Industry, Academia

    Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings. Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss FDA’s framework for using RWE, which was unveiled in December 2018 . The framework is meant to gu...
  • Regulatory NewsRegulatory News

    Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

    Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency. The draft guidance spells out what the agency considers to be an RWD source (i.e. electronic health record data, medical claims or billing data, etc.) and what relevant submissions may include RWE (i.e. single arm trials that use RWE as an ext...
  • Regulatory NewsRegulatory News

    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...
  • Regulatory NewsRegulatory News

    FDA Expands RWE Demonstration Project

    The US Food & Drug Administration (FDA) and Brigham and Women’s Hospital on Wednesday announced they are expanding a demonstration project using real-world evidence (RWE) to predict the results of seven ongoing Phase IV trials. The expanded program means researchers for the first time will estimate the results of randomized controlled trials (RCTs) that have not yet concluded. Funded by FDA’s Center for Drug Evaluation and Research and led by FDA’s Office of Medical Pol...
  • Regulatory NewsRegulatory News

    Continuous Learning: FDA Looks to Wider Adoption

    The work at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on advanced continuous learning for regulatory processes is informing agency-wide efforts. FDA principal deputy commissioner Amy Abernethy touched on how CDRH projects and other initiatives leverage the continuous learning approach during a Wednesday keynote discussion at AcademyHealth’s Health Datapalooza 2019 in Washington, D.C. In an interview with Focus , Ab...
  • Regulatory NewsRegulatory News

    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...