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.
Each year the Foundation conducts an annual meeting, open to the public, to discuss its activities and how it supports FDA. This year's meeting takes place May 4th, from 10 a.m until noon, at the law offices of Alston and Bird (950 F St. NW, Washington, DC) and concludes with a period for brief comments from the public, which can be submitted in advance by emailing eshaefer@reaganudall.org.
"Evolution of FDA Science and Engagement" - a panel discussion
We have reached room capacity so registration to attend the meeting is now closed. We look forward to seeing those who registered before April 19th and thank everyone for your support of the Reagan-Udall Foundation for the FDA. The public is still invited to submit written comments to the Foundation in advance by emailing them to eshaefer@reaganudall.org before May 3rd.
Right-To-Try law not a shortcut to investigational drugs – Expanded Access Navigator can reduce confusion.
Serious or terminally ill patients hoping House passage of federal Right-To-Try legislation will bypass hurdles to unapproved medical treatments need accurate, neutral information now more than ever.
Executive Director June Wasser's talk on the Evolving Scope of the Expanded Access Navigator starts at 11am, Wednesday March 28th and includes an update on its expansion into rare diseases. This year's Expanded Access Programs focus is "Design Sustainable Early Access Programs to Manage Global Complexities and Advance Real-World Evidence" and the two-day event takes place at the Embassy Suites by Hilton in Old Town Alexandria VA. Register at www.cbinet.com/eap
Stop by the foundation's table at NIH's Rare Disease Day on March 1st for a demonstration of the Expanded Access Navigator. It's a website that focused initially on oncology but is adding resources for the rare disease community in 2018.
FDA hopes to bolster its scientific staff in 2018 and this piece in FDA News explains how the Reagan-Udall Foundation's upcoming Fellowship program could funnel talented post-docs into the agency it was created to support.
