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.
The Foundation welcomes questions and discussion about IMEDS at the 33rd 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.
This short MedPage article focuses on the Navigator's step-by-step guided experience for patients and physicians: from identifying treatment and exploring clinical trials to seeking IRB approval and treatment/reporting requirements.
Executive Director June Wasser explains the evolution of IMEDS, the Foundation's public-private, big-data partnership modeled after FDA's Sentinal program.
The Post and other publications picked up CQ-Roll Call's Andrew Siddons' analysis of the potential impact of federal Right-To-Try legislation. Read the article here: the Reagan-Udall Foundation and Navigator are part of the concluding paragraphs about steps FDA has taken to improve the existing expanded access process. Note: the Foundation does not take a position on legislation or influence regulation.
