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# PhRMA Seeks Changes to Protocol Deviations Guide
- URL: https://www.fdaweb.com/phrma-seeks-changes-to-protocol-deviations-guide/
- Published: 2025-03-03T12:00:00.000Z
- Updated: 2026-09-14T14:54:21.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158755

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should make sure its recent draft guidance entitled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices” aligns with other relevant guidances developed by the Internation Conference on Harmonization. Specifically, [PhRMA says](https://downloads.regulations.gov/FDA-2023-D-5016-0048/attachment%5F1.pdf?ref=fdaweb.com) the protocol deviations guidance should align with “E6 (R3) Guideline for Good Clinical Practice” to clarify sponsor and investigator roles and responsibilities related to defining, identifying, documenting, and reporting protocol deviations, as well as for conducting appropriate training and preventing protocol deviation reoccurrence.

PhRMA says it agrees with FDA that sponsors should employ Quality by Design principles when designing and conducting clinical trials to help prevent protocol deviations. Additionally, the group says it is concerned the draft guidance suggests that “all” protocol deviations need to be reported when FDA has previously recommended reporting “important” protocol deviations. It says the agency should revise the guidance to confirm that it recommends the reporting of “all important” or “important” protocol deviations rather than “all” deviations.