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# Comments Sought on ICH Safety Reporting Waivers
- URL: https://www.fdaweb.com/comments-sought-on-ich-safety-reporting-waivers/
- Published: 2017-08-08T12:00:00.000Z
- Updated: 2026-09-14T22:39:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139334

*Federal Register* notice: FDA is seeking comments on an information collection for “Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonization E2C (R2) Format (Periodic Benefit-Risk Evaluation Report).” The guidance is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions, and to enhance efficiency and reduce burden by reducing the number of reports generated for submission to the regulatory authorities. It also provides a common standard for periodic reporting on approved drugs or biologics among the ICH regions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-08/pdf/2017-16647.pdf?ref=fdaweb.com).