REMS Update

Modifications and Revisions on the FDA Guidance

A Risk Evaluation and Mitigation Strategy (REMS) is a required risk management plan that uses tools beyond the prescribing information (the package insert) to ensure that the benefits of certain drugs outweigh their risks.

In the current regulation the FDA stated that any proposed modification to an approved REMS, including proposed changes to materials that are appended to the REMS document, must be submitted as a proposed REMS modification in the form of a prior approval supplement (PAS), and must include a REMS assessment. The guidance states that the proposed modification(s) may not be implemented until approved by the FDA.

FDASIA (Food and Drug Administration Safety and Innovation Act) amended the REMS modification provisions under section 505-1(g) and (h) of the FD&C Act. Section 505-1(h), as amended by FDASIA, requires the FDA to review and act on proposed minor modifications, as defined in guidance, within 60 days It also requires the FDA to establish, through guidance, that certain modifications can be implemented following notification to the FDA. In addition, FDASIA requires the FDA to review and act on REMS modifications to conform the strategy to approved safety label changes, or to a safety label change that the FDA has directed the application holder make pursuant to section 505(o)(4) of the FD&C Act, within 60 days. Finally, FDASIA specifies that proposed REMS modifications no longer require submission of a REMS assessment; instead, proposed modifications must include an adequate rationale for the proposed changes.

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