> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments on ICH RWD Studies Guidance
- URL: https://www.fdaweb.com/comments-on-ich-rwd-studies-guidance/
- Published: 2024-09-04T12:00:00.000Z
- Updated: 2026-09-14T14:40:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157706

The Association for Accessible Medicines (AAM) says it recognizes that the International Council for Harmonization M14 draft guidance on general principles on plan, design, and analysis of pharmacoepidemiological studies that use real-world data for safety assessment of medicines “includes recommendations and high-level best practices for the conduct of observational (noninterventional) pharmacoepidemiological studies that use fit-for-purpose data for safety assessment of medicines.” In its comment [letter](https://www.regulations.gov/comment/FDA-2024-D-2754-0005?ref=fdaweb.com), AAM says the types of data that may be fit-for-purpose will vary depending on multiple factors, including whether the regulatory safety question pertains to a newly-approved drug, or whether there exists an established safety profile for a drug that has been marketed for some time.

The association recommends that regulatory authorities provide opportunities for applicants to consult with the regulatory authority early in protocol development to ensure that the study will generate appropriate, acceptable results.

AAM also provides specific line-by-line edits and comments, as does the [Biotechnology Innovation Association](https://www.regulations.gov/comment/FDA-2024-D-2754-0003?ref=fdaweb.com).