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. 

New analytic tools and methods enhancements have unlocked access to more diverse sources of data than ever before, improving the quality of evidence for safety surveillance. That’s why each year FDA and key leaders from across the Sentinel System stakeholder community invite the public and investigators to attend a public meeting on using electronic healthcare data for post market risk identifications and analysis of medical product safety.

Senator Mike Enzi's remarks reminded attendees that Congress named the Reagan-Udall Foundation for the FDA after two leaders fighting neurodegenerative disorders.

The secret's out, and we're excited to honor the two leaders who will be receiving the inaugural Innovations in Regulatory Science Awards at the Gala December 5th. Here's the press release we shared with media and sponsors.

Curious about public-private partnerships and the Reagan-Udall Foundation for the FDA? Happy to schedule a presentation on our history, vision, mission and opportunities.

Inaugural Reagan-Udall Foundation for the FDA Innovations in Regulatory Science Awards Gala 

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In one powerful blog post, Dr. Gottlieb waives requirements to wait for a full convening of IRBs to approve single patient expanded access treatments, announces the future expansion of the Foundation's Navigator to rare diseases and offers clarity on which adverse events during EA treatment need to be submitted to FDA.

Find our how the Foundation got its start and where it's headed at the Indiana Life Sciences Summit in Indianapolis. Executive Director June Wasser presents a keynote address on the Foundation's mission and public-private partnerships on Tuesday, 10/10.