FDA Posts Final Guidance on REMS Modifications

The FDA has updated its guidance on changes to risk evaluation and mitigation strategies (REMS) with new details on submissions.

The agency lists three kinds of REMS changes — major modifications, minor modifications and revisions — and bases them on their potential impact on information in the REMS related to serious drug risks, safe use of the drug and actions stakeholders must take to follow the REMS.

Major modifications have “substantial” effects and include new information about a drug’s serious risks, safe use or administration, as well as safety labeling changes mandated by the agency and changes to medication guides included in the REMS that require the agency’s approval.