The FDA Foundation Research Program works to accelerate and improve the availability of safe and effective medical products. We do this in several areas:

  • The Innovation in Medical Evidence and Development Surveillance (IMEDS) program includes a subset of the FDA Sentinel Initiative (~90 Million covered lives and all related medically attended events, procedures, and medications) and leverages Sentinel's standardized and quality assured tools, including the Sentinel Common Data Model and query tools to conduct rigorous post-market safety study of medical products.
  • Real-World Data (RWD) resource development(Convenings and Resources to improve RWD and Real-World Evidence) 
  • Regulatory Science (Developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of medical products).

Real-World Evidence Steering Committee

 

News

  • In OMHHE's latest podcast, FDA Foundation’s CEO, Susan Winckler, RPh, Esq. and Research Director, Carla Rodriguez-Watson, PhD, MPH, discuss the RAISE, a project to improve the capture and curation of race & ethnicity data in health care—and the themes that emerged from the RAISE workshop series.

  • Hear RAISE Principal Investigator Carla Rodriguez Watson discuss designing clinical studies for diversity and inclusivity in patient selection on Oracle's Five3One podcast here.

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, MPH, is one of the authors of the Clinical Pharmacology & Therapeutics article, "The Aetion Coalition to Advance Real-World Evidence through Randomized Controlled Trial Emulation Initiative: Oncology" Read more here.

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, MPH, was quoted in POLITICO Pulse coverage of their Next Generation of Health Care Therapies event. Read the full story here.

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, MPH, is among the authors of "Real-World of SARS Cov-2 serology testing in RNA positive patients across the United States, 2023." Read the article here. 

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, MPH, and a few of our colleagues from the COVID-19 Evidence Accelerator authored "Considerations for defining medication exposure when analyzing real-world data.” Read the full commentary here.

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, and Research Associate Kanwal Ghauri are among the authors of "Real-World of SARS Cov-2 serology tests in the United States, 2020." Read the article here. 
     

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, and Research Associate Kanwal Ghauri are among the authors of "Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms’ Fit for Purpose for Safety Outcomes" published in Drug Safety. Read the article here. Learn more about the Foundation's ACE-IT work here. 

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, co-authored "The US Food and Drug Administration Sentinel System: a national resource for a learning health system" published in the Journal of the American Medical Informatics Association. Read the full article here. 

  • The Reagan-Udall Foundation for the FDA launched its first research funding program to evaluate the Real-World Performance of In Vitro Diagnostics (PIVD). Learn more here.

Find more IMEDS News in our IMEDS News Archive.