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.
The Reagan-Udall Foundation has formed a public-private partnership to provide access for private-sector entities, such as regulated industry, academic institutions, and non-profit organizations, to a system based on the Food and Drug Administration’s (FDA) Sentinel Initiative. This collaboration works with selected Sentinel data partners and the Harvard Pilgrim Healthcare Institute, functioning as the Analytic or Coordinating Center, to facilitate the analyses of medical product safety evaluations.
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.
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.
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.