FDA issues required iPledge REMS modifications to isotretinoin manufacturers healio.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from healio.com Daily Mail and Mail on Sunday newspapers.
Isotretinoin manufacturers have 6 months to make five changes to existing iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) requirements for isotretinoin.
The FDA advisory panel meeting was held to address proposed changes to the iPLEDGE REMS to minimize burden on patients, prescribers, and pharmacies while maintaining safe use of isotretinoin.