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Each year, the Reagan-Udall Foundation for the FDA conducts an annual public meeting to discuss its activities in support of the FDA.
Natural History Studies and Registries in the Development of Rare Disease Treatments
The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Diseases Team within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research and the National Institutes of Health’s Division of Rare Diseases Research Innovation within the National Center for Advancing Translational Sciences, is hosting a public workshop.
Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
Qualifying Biomarkers to Support Rare Disease Regulatory Pathways
Case example: Heparan sulfate in neuronopathic lysosomal storage diseases
Public Workshop: In-Person and Virtual
February 21, 2024 | 10am-4pm (eastern)
Advancing Psychedelic Clinical Study Design
Advancing Psychedelic Clinical Study Design
Virtual Public Meeting
Day 1: January 31, 2024 | 10am-2pm (eastern)
Integrating Clinical Studies Into Health Care Delivery: Post-Market Evidence Generation for Medical Products
Integrating Clinical Studies Into Health Care Delivery:
Post-Market Evidence Generation for Medical Products
Virtual Public Meeting
November 14, 2023 | 3:30-5pm (Eastern)
How can FDA and other stakeholders better facilitate and support post-market pragmatic evidence generation studies – studies that answer clinically meaningful questions and address gaps in clinical evidence that directly impact how care is managed in the United States?
Front-of-Package Nutrition Labeling
Front-of-Package Nutrition Labeling
Virtual Public Meeting
November 16, 2023 | 2:30-5pm (Eastern)
On November 16 we convened a Front-of-Package Nutrition Labeling virtual public meeting that included opportunity for stakeholder comment.
Virtual Public Meeting: Strategies for Improving Public Understanding of FDA-Regulated Products
Strategies for Improving Public Understanding of FDA-Regulated Products
Virtual Public Meeting
Public Meeting: Mitigating Risks from Human Xylazine Exposure
Mitigating Risks from Human Xylazine Exposure
Public Meeting: In-person and Virtual
October 4, 2023 | 9:15 am-5 pm (eastern)
The Foundation partnered with the Food and Drug Administration (FDA) to host "Mitigating Risks from Human Xylazine Exposure," a day-long meeting with both in-person and virtual attendance.
2023 Innovations in Regulatory Science Awards
2023 Innovations in Regulatory Science Awards recognize Dr. Collins, Rep. DeGette, Rep. Upton for contributions to regulatory science & public health
Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features
On September 12 and 13, the Foundation, in collaboration with the U.S. Food and Drug Administration, hosted a webinar to explore Good Clinical Practice Considerations for Trials with Pragmatic or Decentralized Features. We convened international experts in the conduct of clinical trials with pragmatic or decentralized features.