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Award presentation and live remarks by Steven Grossman for the Innovations in Regulatory Science Awards on Tuesday, December 10, 2024.

Award presentation and live remarks by Dr. Rachele Hendricks-Sturrup for the Innovations in Regulatory Science Awards on Tuesday, December 10, 2024.

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). This latest session in the webinar series discussed the draft guidance: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice...

On October 30, 2024, we held a one-hour session on the Innovation in Medical Evidence and Development Surveillance (IMEDS) program, a flagship program of the Regan-Udall Foundation for the FDA. IMEDS serves as a national resource to advance the use of FDA tools, including frameworks, guidance documents, and Sentinel initiative tools, in the conduct of real-world data studies to advance public h...

On May 6, 2024, the FDA issued a final rule to regulate Laboratory Developed Tests (LDTs). As part of the Final Rule, FDA outlined a policy to phase out its general enforcement discretion approach to LDTs. This 60-minute education webinar is part one of a series of webinars meant to help laboratories understand FDA’s expectations for a laboratory that offers LDTs. In this first seminar, we disc...

The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Disease Innovation Hub, hosted a public meeting on October 16, 2024. The meeting brought together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the recently announced Rare Disease Innovation Hub can best engage with members of the rare disease community...

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. Welcome - 0:00 Opening Remarks - 3:48 Panel Discussion - 7:43 Public Comment - 1:04:54 Adjourn - 2:07:13

The Reagan-Udall Foundation for the FDA, in support of FDA’s ongoing focus on understanding medical need for PTSD treatment with the goal of facilitating treatment development, convened “Advancing Treatments for Post-Traumatic Stress Disorder,” a public meeting with stakeholder comment. Welcome and Opening Remarks - 0:00 Federal Partner Discussion - 16:12 Stakeholder Comment - 1:03:33 Adjourn -...

The Reagan-Udall Foundation for the FDA, in collaboration with the Bill & Melinda Gates Foundation, hosted a hybrid public workshop on "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence." Session 3: The Next Generation of Gene Therapies 0:00 Session 4: Regulators' Perspective 1:20:52 Session 5: How do we prepare for the next generation of gene therapy, a...

The Reagan-Udall Foundation for the FDA, in collaboration with the Bill & Melinda Gates Foundation, hosted a hybrid public workshop on "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence." Welcome 0:00 Opening Remarks 3:28 Session 1: The Current State of Gene Therapy 18:23 Session 2: Panel Discussion 1:38:45

The Food and Drug Administration (FDA) and the Reagan-Udall Foundation for the FDA convened the fifth Online Controlled Substances Summit. During the Public Session, attendees heard from FDA leadership, including Commissioner Robert Califf, and other experts as they examined the impact and evolution of online purchases of controlled substances and reviewed progress since last year's Summit. Wel...

On July 16, 2024, the Reagan-Udall Foundation for the FDA convened a virtual public meeting on "Implementing the RAISE Action Framework." This meeting served as the introduction to the RAISE Action Framework, an innovative tool designed for leaders and providers within healthcare settings to guide discussions about capturing, curating, and exchanging race and ethnicity data. Welcome 0:30 Openin...

Food Traceability - Chris Waldrop

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." This public workshop explored topics such as the scope of ketamine use, including approved products and compounded products, for these emerging areas of therapeutic interest; potential safety concerns; and ...

Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest - Morning Sessions

RWE Webinar: Considerations Regarding Non-Interventional Studies for Drug and Biological Products

Natural History Studies and Registries in the Development of Rare Disease Treatments - Afternoon

Natural History Studies and Registries in the Development of Rare Disease Treatments - Morning

2024 Annual Public Meeting of the Board of Directors

Qualifying Biomarkers to Support Rare Disease Regulatory Pathways: Afternoon Sessions

Qualifying Biomarkers to Support Rare Disease Regulatory Pathways: Morning Sessions

Advancing Psychedelic Clinical Study Design: Part 2

Advancing Psychedelic Clinical Study Design: Part 1

Innovations in Regulatory Science Awards 2023 Leadership Award

Innovations in Regulatory Science Awards 2023 Innovation Award

Innovations in Regulatory Science Awards 2023 (Advocacy/Policy Award)

Innovations in Regulatory Science Awards 2023 (Commissioner Remarks)

Front-of-Package Nutrition Labeling Virtual Public Meeting (11.16.2023)

Integrating Clinical Studies in Health Care Delivery: Post-Market Evidence Generation (11.14.23)