Advancing Regulatory Science for Public Health

The IMEDS program is offered by the Reagan-Udall Foundation for the FDA through the FDA Amendments Act of 2007. IMEDS serves to advance the science and tools necessary to support post-market evidence generation on regulated products and to facilitate utilization of a robust secondary electronic healthcare data platform for generating better evidence on regulated products in the post-market settings.

FDA encourages leveraging Sentinel capabilities as a national resource for broader public health and safety evidence generation

FDA Commissioner Dr. Robert Califf writes about the value of IMEDS in supporting FDA’s mission in post-market product safety evidence generation

See full post here: Introducing IMEDS, a Public-Private Resource for Evidence Generation

Recent Journal Publication by the Joint IMEDS/FDA/Sentinel Workgroup

Article titled "Design and Analysis Choices for Safety Surveillance Evaluations Need to be Tuned to the Specifics of the Hypothesized Drug-Outcome Association" has recently been published in Pharmacoepiemiology and Drug Safety

The article was written and submitted by investigators of the joint IMEDS/FDA/Sentinel workgroup. To see the article, please click here

The Center for Annotating Research Methods and Analyses (CARMA)

The Center for Annotating Research Methods and Analyses (CARMA) at the University of Illinois, Chicago, funded by the Reagan-Udall Foundation, aims to provide regular summaries of developments in the methods and data used to conduct "real world" evaluations of medical interventions with a particular focus on comparative safety and effectiveness. To find out more about CARMA and how it can be a resource for you, please visit the CARMA website or check out our IMEDS June Community Call.

Reagan-Udall Foundation is Sponsoring the 2nd Seattle Symposim on Health Care Data Analytics

2nd Seattle Symposium on Health Care Data Analytics, Seattle WA: Learning from Electronic Data to Advance Health and Health Care

Sponsored by: Reagan-Udall Foundation for the FDA; Group Health Research Institute, and University of Washington.
Date: Sunday-Tuesday, October 23-25, 2016
Event link:

*IMPORTANT* IMEDS Research Lab Update

As of June 30, 2016, the IMEDS Research Lab will be suspended for the remainder of the year until further notice.

Thank you for your support. For additional information or questions about this update, or to learn more about other areas of the IMEDS program, please contact

IMEDS-Methods Releases the 2015 Scientific Achievements Report

IMEDS-Methods has released its 2015 Scientific Achievements report, which summarizes progress and includes a selection of the key scientific achievements accomplished in 2015.

To download a copy of the report and to learn more about IMEDS-Methods, please visit the IMEDS-Methods page.

Upcoming Events

Join IMEDS for these exciting upcoming events!
August 9, 2015 - Joint Statistical Meetings, Seattle WA: Novel Computational Approaches in Drug Safety Surveillance

August 24, 2015 - ICPE, Boston, MA: Computer Power and Human Reason: From Calculation to Judgment

August 26, 2015 - ICPE, Boston, MA: Identifying Cases in Electronic Health Care Databases: Pitfalls and Best Practices

September 24, 2015 - Big DiP, Boston, MA: Post-Market Safety Surveillance using Administrative Data

To see the full list, please visit our News & Events page.

IMEDS-Methods Releases New Requests for Proposals

The Reagan-Udall Foundation for the FDA is releasing two Request for Proposals. These two requests are for work relating to two of the projects outlined in the 2015 IMEDS-Methods Research Agenda.

For more information, please review the full announcement here.

Announcing the 2015 IMEDS-Methods Research Agenda

The 2015 IMEDS-Methods Research Agenda was formulated to build on the successes achieved during 2014, and to reflect the goals and priorities articulated by all stakeholder groups. The 2015 IMEDS-Methods Research Agenda can be found here.

For more information, please review the full announcement here.

Be a Part of the IMEDS Research Lab

Do you want to know about research that is being completed in the lab? Find out about the IMEDS Research Laboratory, how to gain access, and the available datasets and tools to complete your research. Review the IMEDS Research Lab information.