FDA issues guidance on REMS changes

FDA issued guidance advising pharmaceutical companies on the submission process for modifications and revisions to REMS.

Modifications, which can be categorized as major or minor, involve any changes to a drug's risk message or REMS requirements. Proposals for major changes will require submission of a prior approval supplement (PAS), while proposals for minor modifications may be submitted to FDA using a "changes being effected in 30 days" supplement (CBE-30). ...