MedGuide-Only REMS Will Be The Exception, Not The Norm, As FDA Relaxes Policy
"In most cases" a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.
"In most cases" a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.