Following this puts new work involving it at the top of your briefing, with a note saying why it is there. Links are taken from the source record, never inferred.
FDA supplemental approval of vigabatrin under a Risk Evaluation and Mitigation Strategy (REMS), a regulatory action governing drug safety monitoring and use conditions rather than efficacy evidence.
FDA supplemental approval for a REMS (Risk Evaluation and Mitigation Strategy) program for vigabatrin; indicates regulatory action to manage known safety risks but does not report clinical trial data or efficacy.