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# Guidance on Expanded Access to Investigational Drugs
- URL: https://www.fdaweb.com/guidance-on-expanded-access-to-investigational-drugs/
- Published: 2016-06-03T12:00:00.000Z
- Updated: 2026-09-14T21:07:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135839

*Federal Register* Notice: FDA has published a guidance on “Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers.” The guidance provides information about implementing regulations on expanded access to investigational drugs for treatment use. FDA received a number of questions concerning implementation of its expanded access regulations and is providing the guidance in a question and answer format to address the most frequently asked questions. To view the guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf?ref=fdaweb.com). To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-13165.pdf?ref=fdaweb.com).