> ## 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.

# Guidance on Special Protocol Assessment
- URL: https://www.fdaweb.com/guidance-on-special-protocol-assessment/
- Published: 2016-05-04T12:00:00.000Z
- Updated: 2026-09-14T20:59:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135571

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Special Protocol Assessment.* It provides information about the procedures and general policies adopted by CDER and CBER for special protocol assessment. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interaction between sponsors and FDA. It revises the 5/17/02 guidance for industry of the same title. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM498793.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-04/pdf/2016-10391.pdf?ref=fdaweb.com)