News

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…

In this article, Interim President and CEO Ellen Willmot shares her hope that the Navigator will make it easier for breast cancer physicians and patients to apply for, and benefit from, expanded access to investigational treatments

The American Society of Clinical Oncology helped develop the Navigator and in this post describes it as a clearinghouse for the single-patient expanded access policies of dozens on leading biopharmaceutical companies. 

This post points out that the Navigator will expand from an oncology focus to other therapeutic areas in the future, and walks through a hypothetical Zika case where clear expanded access information would be critical.

This magazine article says the Navigator streamlines information-gathering and links the launch to FDA Commissioner Scott Gottlieb's statements that the expanded access process should be less expensive and time-consuming.

This blog from the Biotechnology Innovation Organization reminds companies they can comply with the 21st Century Cures Act’s requirements to make their expanded access policy publicly available by listing it on the Expanded Access…

Quoting the FDA Voice Blog, this online post mentions the Navigator's public-private partners who help guide patients and physicians through the expanded access process.