FDA's "Project Facilitate" pilot to collect metrics on sponsor expanded access denials

This morning, the U.S. Food and Drug Administration (FDA) announced it launched its new expanded access pilot called "Project Facilitate," a concierge call center under the Oncology Center of Excellence to facilitate the Single Patient IND request process for oncologists.

Under the new program, FDA staff will help guide physicians through the process of applying for expanded access by answering questions, assisting with completing required paperwork, providing information on Institutional Review Boards, and facilitating contact with the drug sponsor for submission of the expanded access request.

Read More: FDA's "Project Facilitate" pilot to collect metrics on sponsor expanded access denials


Share Back To Listing
Loading data