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# FDA Wants Comments on REMS Vendor Changes
- URL: https://www.fdaweb.com/fda-wants-comments-on-rems-vendor-changes/
- Published: 2023-05-24T12:00:00.000Z
- Updated: 2026-09-14T18:33:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154528

FDA is asking for comments on factors that should be considered when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to help implement and manage the strategies. A *Federal Register* [notice](https://www.federalregister.gov/documents/2023/03/23/2023-05962/changes-to-third-party-vendors-for-risk-evaluation-and-mitigation-strategies-establishment-of-a?utm%5Fmedium=email&utm%5Fsource=govdelivery) says that in addition to general factors, such as the requested modification’s effect on patient access and prescribing and administration by healthcare providers, FDA is interested in comments on these topics:

- stakeholder input that the applicant and/or REMS administrator should obtain before developing and implementing a new REMS system, including the extent and timing of stakeholder input;
- whether the sponsor and/or REMS administrator should test changes to the operation of the REMS system before full implementation;
- the amount of time needed to transition stakeholders from one REMS system to another and the factors that go into that time;
- whether the sponsor and/or REMS administrator should conduct a failure modes and effects analysis to identify and plan for system failures; and
- the metrics that the sponsor should capture to evaluate whether the system was successfully and efficiently implemented.