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.
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.
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.