FDA 'Project Facilitate' to Launch by End of May

Posted on 05/17/2019

The FDA held a public workshop on  May 16 to explain its goals for the new pilot aimed at improving patient access to unapproved oncology drugs.  The pilot is referred to as 'Project Facilitate'.  Dr. Richard Pazdur, Director of FDA's Oncology Center of Excellence announced the pilot will debut at the end of May.  The goal of Project Facilitate is to assist physicians and patients navigate through the single patient Investigational New Drug [IND] process, dubbed SPI.  Project Facilitate FDA staff will operate a call center for oncology products, facilitate completion of the required FDA Form 3926, and identify Institutional REview Board (IRB) resources.  Project Facilitate will also gather metrics on whether a company provides a drug or not, and if not, try to document the company's reason for declining a request.