MedGuide-Only REMS Will Be The Exception, Not The Norm, As FDA Relaxes Policy
This article was originally published in The Pink Sheet Daily
Executive Summary"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a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.
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There is concern that common software package could mean more drugs end up with risk management programs.
GPhA says congressional action is only remedy after study estimates $5.4 billion in potential savings is lost annually because of brand manufacturers using REMS to prevent generic competition.
FDA says Novartis’ assessment of the long-acting beta agonist’s REMS, which consisted only of a communication plan, shows the “plan, and therefore the REMS, has met its goal.”