From our Annual Public Meeting to topic-specific convenings, the Reagan-Udall Foundation for the FDA brings stakeholders together on matters critical to regulatory science and practice. These events, often hosted at the request of FDA leadership, provide space for expert analysis and candid discussion on FDA’s priority issues. See below for upcoming events.

Upcoming Events

Primary Mitochondrial Diseases
The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), will host a virtual, public workshop to explore opportunities to optimize therapeutic development to address primary mitochondrial diseases.

Past Events

Real-World Evidence Webinar Series: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), hosted a public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE).
Introduction to Innovation in Medical Evidence and Development Surveillance (IMEDS): The Research Resource
On October 30, 2024, we held a one-hour session on IMEDS, a flagship program of the Regan-Udall Foundation for the FDA.
Biosimilar Roundtables
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.
LDT Industry Education: Record Keeping and Adverse Event Reporting
Record Keeping and Adverse Event Reporting: Medical Device Reporting, Corrections and Removals and Quality System Complaint Requirements LDT Industry Education
Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub
The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Disease Innovation Hub, hosted a public meeting on October 16, 2024.
Virtual Public Meeting on FDA's Final Rule on Requirements for Additional Traceability Records for Certain Foods
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.
Advancing Treatments for Post-Traumatic Stress Disorder
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.
Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence
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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Online Controlled Substances Summit
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
Implementing the RAISE Action Framework Webinar July 16, 2024 | 2-3pm (eastern)