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# PhRMA Comments on Safety Reporting Guidance
- URL: https://www.fdaweb.com/phrma-comments-on-safety-reporting-guidance/
- Published: 2021-12-02T12:00:00.000Z
- Updated: 2026-09-14T17:24:22.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150684

Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on investigator responsibilities for safety reporting for investigational drugs and medical devices “will help further ensure a consistent approach to safety and safety reporting throughout the entire medical product development process.” In its 11/29 comment [letter](https://downloads.regulations.gov/FDA-2021-D-0368-0007/attachment%5F1.pdf?ref=fdaweb.com), the association says it agrees with FDA that clearly defined roles and responsibilities are important for effective safety surveillance.

In addition to its general support for the draft, PhRMA submits specific and line-by-line comments.