Meetings

  • Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda - A Workshop Date: May 9, 2018 (8:30 AM Eastern)

    An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) will plan and conduct a three-part workshop series to be held over the course of a two-year period. As part of FDA's continued focus on building a national governance system for evidence generation, the proposed focus of these workshops will be on the generation and utilization of real-world evidence to evaluate efficacy, effectiveness, tolerability, and safety for both review of new indications and postapproval studies. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.
  • Harnessing Mobile Technology to Predict, Diagnose, Monitor, and Develop Treatments for Nervous System Disorders: A Workshop Date: June 5, 2018 - June 6, 2018 (1:30 PM Eastern)

    The Forum on Neuroscience and Nervous System Disorders will host a public workshop to help advance the appropriate use of devices and mobile technology to predict, diagnose, monitor, assess adherence, and develop treatments for CNS disorders
  • Understanding Disparities in Access to Genomic Medicine: A Workshop Date: June 27, 2018 (8:30 AM Eastern)

    The Roundtable on Genomics and Precision Health will host a public workshop on June 27, 2018 to explore disparities in access to genetic/genomic services that exist across different segments of the population (e.g., in medically underserved areas and populations, across different racial/ethnic groups, and socioeconomic levels). The workshop may discuss model programs of care for diverse patient populations, with a focus on examining current challenges, approaches, and best practices for alleviating disparities in access, which may include the geographic distribution of providers and services and the potential role of telemedicine. Workshop discussions may also focus on insurance coverage for genetic/genomic services, along with the financial costs for patients of genetic testing and downstream care.
  • Examining the Impact of Real-World Evidence on Medical Development: Application Date: July 17, 2018 - July 18, 2018 (8:30 AM Eastern)

    An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) will plan and conduct a three-part workshop series to be held over the course of a two-year period. As part of FDA's continued focus on building a national governance system for evidence generation, the proposed focus of these workshops will be on the generation and utilization of real-world evidence to evaluate efficacy, effectiveness, tolerability, and safety for both review of new indications and postapproval studies. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.