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,…
The Expanded Access Navigator, or EA Navigator, represents a unique partnership between the Reagan-Udall Foundation for the FDA, patient advocacy organizations, the pharmaceutical industry, and the federal government to provide clear, digestible information on single-patient EA.
Operational Evaluation of
FDA’s Tobacco Program
The tobacco operational evaluation began September 21, 2022. The evaluation will address the Center for Tobacco Products' programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The panel will not address tobacco policy issues, which are outside the scope of this evaluation.
The report is due to Commissioner Califf on December 19, 2022. We are currently in the Report Generation stage of this project.
Evaluation of FDA’s Human Foods Program
Independent Expert Panel submitted report to FDA Commissioner
On December 6, 2022, the Independent Expert Panel for Foods submitted its report on the Operational Evaluation of FDA’s Human Foods Program to FDA Commissioner Dr. Robert Califf. The evaluation and report were facilitated by the Reagan-Udall Foundation at Dr…
FDA Operational Evaluation
As announced on July 19, 2022, the Reagan-Udall Foundation will conduct an operational evaluation of FDA’s human foods and tobacco programs.
The United States is facing an overdose crisis. Over 107,000 Americans died of drug overdoses in 2021, according to the Centers for Disease Control and Prevention’s provisional estimates. According to the Department of Health and Human Services (HHS), the overdose crisis has evolved over time and is now largely characterized by deaths involving illicitly manufactured synthetic opioids, including fentanyl, and, increasingly, stimulants. The Reagan-Udall Foundation for the FDA supports the U.S. Food and Drug Administration’s work to develop strategies for the…
The Reagan-Udall Foundation for the FDA is partnering with the FDA's Center for Veterinary Medicine (CVM) to explore the development of a public-private partnership framework for collecting and analyzing real-world data regarding antimicrobial use (AMU) in food-producing animals.
Food plays a significant role in public health, from the quality and safety of the food supply to the nutrition it provides. Nutrition-related chronic diseases, such as heart disease and cancer, are the leading cause of death and disability in the United States. Nearly one in three adults in the U.S. have high blood pressure, which can lead to heart disease and strokes, and 13 percent have diabetes. A staggering 70 percent of U.S. adults are overweight, with roughly 40 percent classified as obese. Among children and adolescents, almost one in five are obese.…
Our COVID-19 Hub includes a Directory of Companies Developing COVID-19 Therapies, a searchable listing of relevant Clinical Trials and Expanded Access Opportunities culled from ClinicalTrials.gov, and links to the latest FDA, CDC, and NIH updates. In addition to medical interventions, the COVID-19 Hub also links to critical FDA resources for consumers and industry focused on food and veterinary safety.
FDA Patient Listening Sessions are one way patient communities and FDA staff connect about the experiences of living with specific diseases and conditions. The Reagan-Udall Foundation works closely with the Patient Affairs team in FDA’s Office of Clinical Policy and Programs/Office of the Commissioner to conduct these small, informal discussions. Patients, caregivers, and advocates provide personal insight into the day-to-day challenges of living with a specific disease with staff from FDA’s medical products centers: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health.
Big Data For Patients (BD4P), a replicable training program, gives patient advocates a basic understanding of the science and enables full and effective participation in big data initiatives. Developed with multiple stakeholder groups, the program includes tools and best practices accessible on this site.