What information goes into the Proposed REMS and what goes into the Supporting Document?
We look at the Proposed REMS as an overview of the REMS program that will be made publically available on the FDA website. In general, companies have chosen to limit the information in the Proposed REMS; for example, listing only the timetable for when assessments will occur, but not describing what will be measured and how. The details behind the overview are generally described more fully in the REMS Supporting Document, including description of tools and protocols that may or may not be appendices to the Proposed REMS.
