Coverage

FDA Eases Access to Unapproved Cancer Drugs - OBR Daily
"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 clinical trial. But there are some patients who may need access to investigational drugs outside the realm…
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Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies - The ASCO Post
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019…
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FDA Launches Expanded Access Pilot ‘Project Facilitate’ - Regulatory Focus
The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.  
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FDA, Reagan-Udall launch end-to-end expanded access program for cancer - BioCentury
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 expanded access to oncology drugs. The…
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Sharpless Calls for a Nimble, Flexible, More Efficient US FDA - Pinksheet
"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, he acknowledged that outside…
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Sharpless Begins to Learn the Ropes While FDA Center Directors Look to the Future
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”
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CDER 2018 Drug Safety Priorities Report
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.”  
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FDA to facilitate access to unapproved drugs
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-get-expanded-access-unapproved-drugs
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The FDA Sentinel Initiative: An evolving National Resource
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. 
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Coming soon for Expanded Access Policies
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.
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