Through IMEDS, the FDA Foundation provides access to FDA-quality data to facilitate the analyses of medical product safety evaluations for private-sector entities, such as regulated industry, academic institutions, and non-profit organizations.

The IMEDS Network engages a subset of the FDA’s Sentinel Network as a national resource for broader public health and medical evidence generation.

IMEDS facilitates studies that increase understanding of the real-world safety and effectiveness of pharmacologic therapies.

Benefits of using IMEDS:

  • Access to large volume of patient data
  • Reliability of an established network
  • Direct experience and expertise leveraging FDA’s Sentinel Common Data Model and tools
  • Accessing and contributing to collective knowledge building around real-world evidence generation


  • The Society for Epidemiological Research Annual Meeting was held virtually June 22-25, 2021. The meeting brings together epidemiologists from all stages, from scholars to senior scientists, to discuss emerging epidemiologic research. This year, the FDA Foundation's IMEDS work was featured in a poster session on “Master Protocol and parallel approach to analyze angioedema in patients with heart failure.” View poster

  • FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, co-authored the manuscript "The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology" published in Pharmacoepidemiology & Drug Safety. The manuscript focuses on narrative electronic prescribing instructions (NEPI), text which provides information from a prescriber about the administration of a medication. The paper evaluates how NEPIs are used in research, the challenges and opportunities for their broader application, and recommendations for their wider use. Read more

  • Saama's "Active Surveillance: A New Paradigm in Patient Safety" webinar featuring Carla Rodriguez-Watson, PhD, MPH, IMEDS Scientific Director

  • Nominations Open for IMEDS Steering Committee

  • CDER's  2018 Drug Safety Priorities Report features IMEDS

  • published in the New England Journal of Medicine, Platt, R, Brown, J., Robb, M., McClellan, M., Ball, R., Nguyen, M., and Sherman, R., The FDA Sentinel Initiative--An Evolving National Resource, 379;22, 2091-2, Copyright © (2018) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

Find more IMEDS News in our IMEDS News Archive.