2023-05962: Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies; Establishment of a Public Docket; Request for Comments
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The Food and Drug Administration (FDA, Agency, or we) is announcing the establishment of a docket to solicit comments on factors that generally should be considered by the Secretary of Health and Human Services (Secretary) 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 aid in implementation and management of the strategies.
The agency’s own summary, as published.
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