iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements

Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.

Isotretinoin
US FDA advisory committee to vote on changes to isotretinoin iPLEDGE REMS • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers