During Nature Conferences' "Breaking Barriers for Gender and Health Equity Through Research" virtual event held earlier this week, the Foundation's Carla V. Rodriguez-Watson, PhD, MPH participated in a session on Sex and Gender in Clinical Trials and Health Research. During the session, Dr. Rodriguez-Watson discussed the lack of women and racial and ethnic subgroups in clinical trials, and how we can improve race and ethnicity in real-world data to support diversity in these trials. Watch the full session here: https://lnkd.in/gS9FipUR
Reagan-Udall Foundation for the FDA
Non-profit Organizations
Washington, DC 4,610 followers
Advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety
Über uns
The Reagan-Udall Foundation is an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of the FDA by advancing regulatory science and research. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to bring all parties to the table (FDA, Patient Groups, Academia, other Government entities, and Industry) to work together in a transparent way to create exciting new regulatory science.
- Website
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http://www.reaganudall.org/
External link for Reagan-Udall Foundation for the FDA
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- Non-profit Organizations
- Größe des Unternehmens
- 11-50 Mitarbeiter
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- Washington, DC
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- Nonprofit
- Gegründet
- 2007
- Spezialitäten
- Regulatory Science, Public Private Partnerships, Medical Evidence Development & Surveillance, and Public Health
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Primäre
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Employees at Reagan-Udall Foundation for the FDA
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Susan Winckler
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David Fajgenbaum, MD, MBA, MSc
Physician-Scientist @ UPenn | National Bestselling Author, Chasing My Cure | Co-Founder @ Every Cure & CDCN
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Carla V. Rodriguez-Watson, PhD, MPH
Director of Research at Reagan-Udall Foundation for the FDA
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Kathleen Spaeth
Brand Builder/Writer/Mar-Com Pro/Problem Solver
Aktualisierungen
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Did you miss our "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence" hybrid public workshop? All materials are now available on our website. Review the slides, read the transcript, and watch the full recording or a specific session: https://lnkd.in/em7t6zxn
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openFDA makes it easy to incorporate FDA information into your software application. Our report, “Improving Access to Publicly Available FDA Information,” explores making FDA publicly available information easier to access. Read it here: https://lnkd.in/eM6rmu4U
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Reagan-Udall Foundation for the FDA reposted this
Leading Regulatory Science and Innovation for the Food and Drug Administration => I post, like, and reply based on my interests and experience, and I do not represent views of my employer."
*STD* 👉 The 2024 #FDA Scientific Computing and Digital Transformation Symposium is two months away. Mark Palmer, M.D., Ph.D. and I will co-present the in silico white paper from the Reagan-Udall Foundation for the FDA (link in comments). Hope you can join us in-person! Cheers. https://lnkd.in/gd-Mrbjm
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Join us and the FDA Rare Disease Innovation Hub for a hybrid public meeting that will bring together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the recently announced Hub can best engage with members of the rare disease community and prioritize this work. During this public meeting, FDA seeks to gather stakeholder input. Click here for more information and to register: https://lnkd.in/epxcdyZk
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#ExpandedAccess may be an option for patients with life-threatening diseases or conditions to try investigational medical products when no satisfactory or approved therapies are available and there is no opportunity for the patient to enroll in a clinical trial. Learn more about Expanded Access and how it can help your patients here: https://lnkd.in/dvgFxkS #physicians #healthcare
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Last week's hybrid public meeting on "Advancing Treatments for Post-Traumatic Stress Disorder" featured opening remarks from FDA's Dr. Bernard Fischer along with a federal partner discussion exploring efforts to accelerate treatment development for PTSD with the United States Department of Defense's Dr. Elyse Katz, U.S. Department of Health and Human Services (HHS)'s Leith States, MD, MPH, MBA FACPM, FDA's Dr. Marta Sokolowska, Substance Abuse and Mental Health Services Administration (SAMHSA)'s Neeraj Gandotra MD, and U.S. Department of Veterans Affairs' Dr. Paula Schnurr and Dr. Miriam Smyth. Meeting materials, including the recording and transcript, will be available on the Foundation website later this week.
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That concludes today's "Scientific Advancements in Gene Therapies: Opportunities for Global Regulatory Convergence" hybrid public workshop. Thank you to everyone who attended and participated. Workshop materials, including the workshop recording and transcript, will be available on the Foundation website next week.
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Hannover Medical School’s Dr. Hildegard Büning, Yale University School of Medicine’s Dr. Cecelia Calhoun, World Health Organization’s Dr. Jeremy Farrar, Muhimbili University of Health and Allied Sciences (MUHAS) Dr. Julie Makani, FDA’s Dr. Peter Marks, World Health Organization Regional Office for Africa’s Dr. Kwasi Nyarko, and gene therapy recipient Jimi Olaghere answer the question: How do we prepare for the next generation of gene therapy, as industry, regulators, and a health care system?
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Spanish Medicines Agency’s Dr. Sol Ruiz, FDA’s Dr. Peter Marks, and Food and Drugs Authority,Ghana’s Eric Karikari-Boateng provide the regulators’ perspective on gene therapies.