News Coverage

FDA Eases Access to Unapproved Cancer Drugs By Christina Bennett, MS "Patients with cancer are treated with drugs already approved by the U.S. Food and Drug Administration (FDA) or with an investigational agent in a...
Read the ASCO Post article about FDA's Project Facilitate and the collaboration with the Foundation's Expanded Access Navigator. https://www.ascopost.com/issues/july-10-2019/project-facilitate/
"In a separate announcement, the Reagan-Udall Foundation for the FDA on Monday said it has enhanced its Expanded Access Navigator to include expanded access programs registered with ClinicalTrials.gov." Read the...
FDA's Oncology Center of Excellence and the Reagan-Udall Foundation launched Expanded Access Navigator and Project Facilitate, two separate but coordinated pilot programs to provide patients and physicians with...
"Sharpless said FDA's organization also must ensure collaboration across disciplines and locations, as well as with outside groups. In a speech to the Reagan-Udall Foundation annual meeting later in the day, though,...
Read Zach Brennan’s reference to the Foundation's Annual Public Meeting in his Regulatory Focus™ article:  “Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future”
New Drug Safety Priorities Report for 2018 highlights CDER’s safety work with a reference to our IMEDS program that "allows public and private entities access to the Sentinel System.”  
Biocentury coverage on the FDA’s expanded access program and collaboration with the Reagan-Udall Foundation is available here: https://www.biocentury.com/biocentury/regulation/2018-12-14/how-fda-plans-help-patients-...
Read The FDA Sentinel Initiative—An Evolving National Resource pubished in New England Journal of Medicine in November 2018 by Platt et al featuring our IMEDS program.  Sourced from Platt, R, Brown, J.,...
Updates are coming to expanded access procedures and data use. Read the latest from FDA Law Blog featuring key messages from our public meeting on leveraging expanded acccess data.
Pink Sheet featured an article authored by Kate Rawson which highlights important takeaways from our public meeting, Leveraging Real-World Treatment Experience from Expanded Access Protocols on November 19, 2018 at...
Mark McClellan and his colleagues at Duke-Margolis Health Policy Center outline how real-world evidence can increase value in health care in this Growth Commentary referencing Reagan-Udall Foundation for the FDA’s...
Dr. Scott Gottlieb indicated that the upcoming changes to the FDA Office of New Drugs would likely be in place this summer, when taking questions at the Foundation's Annual Public Meeting in this article from RAPS...
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...
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...
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...
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...
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...
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/...
Executive Director June Wasser explains the evolution of IMEDS, the Foundation's public-private, big-data partnership modeled after FDA's Sentinal program. IMEDS is one way FDA hopes to transform healthcare claims...
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...
Richard A. Moscicki, M.D.'s post explains how FDA receives more than 1,000 expanded access applications a year and calls the Navigator the first consolidated starting point for researching available investigational...
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...
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...
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...
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-...
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...
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.