- About
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Projects
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Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
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Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
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Column 1
- News and Events
- Expanded Access eRequest
Past Events
On October 30, 2024, we held a one-hour session on IMEDS, a flagship program of the Regan-Udall Foundation for the FDA.
The Reagan-Udall Foundation for the FDA conducted a series of five closed-door virtual roundtable conversations with biosimilar developers to explore emerging areas of regulatory science and to create a space for active discussion and exploration between FDA and biosimilar developers.
Record Keeping and Adverse Event Reporting:
Medical Device Reporting, Corrections and Removals and Quality System Complaint Requirements
LDT Industry Education
The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Disease Innovation Hub, hosted a public meeting on October 16, 2024.
On October 7, we hosted a virtual public meeting to hear insights on the Final Rule on Requirements for Additional Traceability Records from both FDA leadership and other experts from across food industry sectors.
The Reagan-Udall Foundation for the FDA, in support of FDA’s ongoing focus on PTSD, convened “Advancing Treatments for Post-Traumatic Stress Disorder,” a public meeting with stakeholder comment.
The Reagan-Udall Foundation for the FDA, in collaboration with the Bill & Melinda Gates Foundation, will host a hybrid public workshop on "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence."
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The Food and Drug Administration (FDA) and the Reagan-Udall Foundation for the FDA convened the fifth Online Controlled Substances Summit.
Implementing the RAISE Action Framework
Webinar
July 16, 2024 | 2-3pm (eastern)
The Reagan-Udall Foundation for the FDA, in collaboration with the FDA, hosted a hybrid public workshop on "Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest."