> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Senate Committee Probes FDA Expanded Access Program
- URL: https://www.fdaweb.com/senate-committee-probes-fda-expanded-access-program/
- Published: 2016-02-22T12:00:00.000Z
- Updated: 2026-09-15T02:37:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134840

> The Senate Committee on Homeland Security and Governmental Affairs has asked FDA to explain why it has not finalized a 2/2015 draft guidance to streamline drug expanded-access requests to allow patients access to investigational therapies outside of a clinical trial. In a [2/18 letter](http://www.hsgac.senate.gov/download/chairman-johnson-letter-to-fda?ref=fdaweb.com) to the agency, the committee asked for the timeline the agency expects for implementing the streamlined application. The letter also asked how adverse event data reported under the expanded-access program are used in regulatory decision making. Additionally, it asked the agency to describe the process used to review emergency-use or expanded-access requests during the Ebola crisis.