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. 

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 5^th, 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.

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The Foundation welcomes questions and discussion about IMEDS at the 33^rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management Aug 26-30. Stop by Booth 45 for a personal discussion of IMEDS capabilities.

Dateline: Washington, D.C.

The Reagan-Udall Foundation for the FDA launches Navigator website to share resources and policies on expanded access to investigational therapies.

Saving time is critical for physicians treating seriously ill patients who have exhausted alternatives to expanded access. So Forbes contributor Alison Bateman-House explains how the Navigator spells out timelines in this piece called "How To Try An Experimental Drug When You Don't Qualify For A Clinical Trial."

In the article, Wasser explains why the FDA asked its foundation to create a public-private partnership launching the Navigator. Legislation like the 21st Century Cures Act and changes in regulation require drug companies to make any expanded access policies and contact information public. The Navigator streamlines the way to find that information.