New Drug Safety Priorities Report for 2018 highlights CDER’s safety work with a reference to our IMEDS program that "allows public and private entities access to the Sentinel System.”
Biocentury coverage on the FDA’s expanded access program and collaboration with the Reagan-Udall Foundation is available here: https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-get-expanded-access-unapproved-drugs
Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New England Journal of Medicine in November 2018 by Platt et al featuring our IMEDS program.
Updates are coming to expanded access procedures and data use. Read the latest from FDA Law Blog featuring key messages from our public meeting on leveraging expanded acccess data.
Executive Director June Wasser will present Collecting Data from EA Treatment for Regulatory Submissions at the Life Science Compassionate Access Summit at 4:00 pm, Monday, March 18th in Philadelphia. She will focus on:
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.
