"Urgent" FDA Request for Alvilmopan REMS Data

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Donald McKaig
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"Urgent" FDA Request for Alvilmopan REMS Data

Received an "urgent" request last night (6PM) from the Alvilmopan REMS program for transaction data from Jan 25-present. We were given timeline to submit data by 10 am this morning which obviously is a very quick turnaround. Stated this was part of an FDA inspection of this REMS program. Has anyone else received similar requests?