We're excited to honor two longtime U.S. Food and Drug Administration leaders and an independent public-private partnership as the 2018 recipients of the Innovations in Regulatory Science Awards to be honored on December 4, 2018.
Our Executive Director June S. Wasser has agreed to serve on the advisory panel for a new initiative of the Grocery Manufacturers Association Science and Education Foundation (GMA SEF). In this capacity Wasser will be an external reviewer of the next instructional unit being developed for the Hands On: Real World Lessons for Middle School Classrooms program. The current curriculum, often referred to as Hands On: Food Safety is being used in over 30 states and has reached more than 64,000 students, and 1,000 teachers since its inception.
Expanded access programs, sometimes also called “compassionate use” programs, provide patients with serious or immediately life-threatening diseases or conditions access to investigational products outside of clinical trials
Mark McClellan and his colleagues at Duke-Margolis Health Policy Center outline how real-world evidence can increase value in health care in this Growth Commentary referencing Reagan-Udall Foundation for the FDA’s IMEDS program.
During the ICPE conference, our Executive Director, June Wasser, will be discussing the importance of the Foundation’s IMEDS (Innovation in Medical Evidence Development and Surveillance) program, which provides a framework and entry point for private-sector entities, such as regulated industry and other researchers into FDA’s Sentinel System. Wasser will be joined by Jeffrey Brown, PhD, of Harvard Pilgrim Health Care Institute, which serves as the analytics center for IMEDS studies.
The Reagan-Udall Foundation for the Food and Drug Administration is pleased to announce the call for nominations for the 2018 Innovations in Regulatory Science Awards. The Foundation will be honoring the leadership and achievements of those whose work represents the progress and promise of regulatory science and advocacy.
Collaboration and partnership, two key aspects of the Reagan-Udall Foundation for the FDA’s commitment to advancing regulatory science, were on full display when leaders from the FDA, the regulatory science community and the medical community gathered in Washington DC on Friday May 4, 2018 for the Foundation’s annual meeting.
Dr. Scott Gottlieb indicated that the upcoming changes to the FDA Office of New Drugs would likely be in place this summer, when taking questions at the Foundation's Annual Public Meeting in this article from RAPS.
Stop by booth #622 to learn more about the Foundation and our programs including, Innovation in Medical Evidence Development and Surveillance (IMEDS), the Expanded Access Navigator, and our Fellowship initiative.
The Reagan-Udall Foundation for the FDA's Executive Director, June Wasser, was a presenter on a June 6th webinar sponsored by Johnson & Johnson and NYU Langone Health. She explained how patients use the Foundation's Expanded Access Navigator. The Navigator was launched in June 2017 and serves as a clearinghouse of neutral information on the process physicians use to request expanded access to investigational therapies under development by biopharmaceutical companies.
