Projects

The FDA Foundation Research Program works to accelerate and improve the availability of safe and effective medical products. We do this in several areas:

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.

The Reagan-Udall Foundation for the FDA is leading a stakeholder dialogue process to explore new strategies for produce safety and the development of a collaborative entity to drive progress. Ensuring the safety of fruits and vegetables requires a holistic approach. To aid in the goal of improved protection of public health and establishing a collaborative entity, the Foundation is collaborating with stakeholders from agricultural communities, industry, academia, and government to develop a shared understanding of the challenges and a vision for protecting…

The Reagan-Udall Foundation for the FDA is leading an initiative to identify holistic approaches to address opportunities and challenges in animal health and veterinary medicine.

The project set out to discover what patients, caregivers, healthcare professionals, and researchers want to know about FDA-regulated medical products (drug and biologics); where they seek this information; what FDA data are publicly available for external sources to utilize in generating query responses.

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…

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,…