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# Detailed Comments on Protocol Deviations Draft Guide
- URL: https://www.fdaweb.com/detailed-comments-on-protocol-deviations-draft-guide/
- Published: 2025-02-25T12:00:00.000Z
- Updated: 2026-09-14T14:53:58.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5158717

Two stakeholders have submitted specific, line-by-line, technical comments on an FDA draft guidance on protocol deviations for clinical investigations of drugs, biological products, and devices. The comments were submitted by [Labcorp](https://www.regulations.gov/comment/FDA-2023-D-5016-0030?ref=fdaweb.com) and [AstraZeneca](https://www.regulations.gov/comment/FDA-2023-D-5016-0029?ref=fdaweb.com).