ARTICLE | Politics & Policy
FDA issues guidance on REMS changes
April 8, 2015 12:31 AM UTC
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). ...