The FDA encourages the leveraging of Sentinel capabilities through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program as a national resource for broader public health and medical evidence generation. Besides surveillance activities, the IMEDS distributed database can be used for population characterization and effectiveness studies. IMEDS projects must be scientifically suitable for use by the database and should address a safety concern of public health interest. Examples are exposures to medical products, exposure-outcome relationships, or impact of risk mitigation activities.
The Reagan-Udall Foundation provides educational opportunities to learn more about how to use the IMEDS database to answer important post-market research questions. Please contact us directly at IMEDS@reaganudall.org for more information.
Strategic Framework/Commitment to Transparency (in the process of being updated)