Extract to table

§ 355-1(a)(1) The statute enumerates six factors that FDA must consider in determining whether a REMS is necessary

§ 355-1(d), a REMS must include a timetable for submission of assessments of the REMS to FDA

50(d)(5)(viii), which provides that an NDA or supplement must include information pertinent to the evaluation of the need for a REMS

Accordingly, the inclusion of a REMS assessment section in the sNDA is not discretionary; it is a regulatory expectation that must be met to avoid a Refuse to File action or a delay in the review cycle

50(d)(5)(viii) and FDA's explicit direction at the Type B Pre-sNDA meeting, the sNDA must include a REMS assessment section