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# PhRMA Supports Post-Approval Safety Guidance
- URL: https://www.fdaweb.com/phrma-supports-post-approval-safety-guidance/
- Published: 2024-05-22T12:00:00.000Z
- Updated: 2026-09-14T14:31:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157044

Pharmaceutical Researchers and Manufacturers of America says revision of the International Council for Harmonization E2D(R1) guidance on definitions and standards for managing and reporting individual case safety reports (ICSRs) on post-approval safety data “is an important step towards consideration of how new and emerging data sources should be addressed in the context of post-approval individual case safety reporting, as well as good management practices.” The association's comment [letter](https://downloads.regulations.gov/FDA-2024-D-0803-0005/attachment%5F1.pdf?ref=fdaweb.com) includes comments in four areas:

- categorization of adverse events via E2B (R3) data elements;
- reference to regional requirements;
- reference to digital devices; and
- management of ICSRs in view of new and emerging data sources.