"While the details of the REMS are still being worked out, we do not believe that the approved REMS will be substantially different from the existing risk management plans unless new safety information suggests that the existing plan is not working"
Isotretinoin manufacturers waiting to see if iPLEDGE will meet FDA's new safety guidelines National report - Manufacturers of isotretinoin are awaiting more information to determine whether iPLEDGE - the ... via Dermatology Times
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[Source: Pregnancy News]
