The FDA Foundation Research Program works to accelerate and improve evidence generation for the assessment of the risks and benefits of regulated products.

Through its Medical Evidence and Development Surveillance (IMEDS) program, 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 Foundation has engaged with regulated industry to develop protocols, statistical analysis plans, and execute long-term post-market required safety studies.

In our real-world data work, we're developing and applying a framework to evaluate and conduct algorithm validation studies.

News

  • 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.

  • 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

Find more IMEDS News in our IMEDS News Archive.