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# Guide on Special Protocol Assessments
- URL: https://www.fdaweb.com/guide-on-special-protocol-assessments/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141235

*Federal Register* notice: FDA has made available a guidance entitled “Special Protocol Assessment (SPA)” that provides information about the procedures and general policies adopted by CDER/CBER for such assessments. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and the interactions between sponsors and the agency. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07871.pdf?ref=fdaweb.com).