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
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.
Nominations are now being accepted for the Innovations in Regulatory Science Awards. These awards will be presented at the inaugural Innovations in Regulatory Science Awards Gala on December 5th, 2017 at the Kaiser Permanente Center for Total Health in Washington, D.C.
The Innovations in Regulatory Science Awards will be presented in two categories to honor individuals and organizations for their accomplishments and service to regulatory science and public health.
Executive Director June Wasser leads a 1:45pm session Tuesday, 9/26 on how the Navigator started and resources it shares with patients and physicians.
Dr. Joette Giovinco shared the launch of the Expanded Access Navigator in a Fox Medical Team TV and online report. She credited the FDA and advocacy groups who provided input for the online tool and the clip shows how companies are listing single patient expanded access therapies in the Navigator’s Directory.
