Pink Sheet featured an article authored by Kate Rawson which highlights important takeaways from our public meeting, Leveraging Real-World Treatment Experience from Expanded Access Protocols on November 19, 2018 at the FDA White Oak Campus. Find the summary and access to the article below.

Executive Summary

Formal reg not needed, according to agency; officials agree that regulatory flexibility is best way to offer sponsors advice, saying data collected during compassionate use can be helpful in guiding regulatory decisions.

The Reagan-Udall Foundation for the Food and Drug Administration expands its leadership with the appointment of three new Board members: Andrew C. von Eschenbach, M.D., former FDA Commissioner; Edward John Allera JD, pharmacist and attorney with expertise in FDA regulation and biotechnology; and, Lynne Zydowsky, Ph.D., a biotechnology and life science executive.

Read the full press release here.

See Event Highlights and Download the Meeting Report 

Monday, November 19, 2018   |  10:00 AM to 4:30 PM

U.S. Food and Drug Administration
White Oak Campus, Building 31, Great Room
10903 New Hampshire Avenue, Silver Spring, MD 20993 

The Reagan-Udall Foundation for the FDA honored 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.

This year’s Innovations in Regulatory Science Awards Dinner, a premier event launched in 2017, brought together leaders in academia, advocacy, industry and government to celebrate the achievements and continued contributions of outstanding regulatory science leaders.

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.