Progress Continues on Resolving iPLEDGE Data and Access Issues Today, FDA issued an update on the continued progress made by the Isotretinoin Products Manufacturers Group (IPMG) regarding iPLEDGE REMS data and access issues. The IPMG recently created a new tool within the iPLEDGE REMS system to help resolve account access for some user groups without using the call center. The new tool allows prescribers & designees to send login links to their patients' email via the Manage Patients page of the iPLEDGE REMS portal. Users should check their email, including spam folders, for messages from iPLEDGE. We share the frustration & disappointment of many iPLEDGE users about the duration of interruption & impact on access to treatment. There has been progress with many users gaining access to their accounts, but there is still work to be done. FDA will continue to meet with IPMG about the problems with the iPLEDGE REMS and will update iPLEDGE users and the public on IPMG's progress towards having the system work as intended for all users. |
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