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FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training

This article was originally published in The Pink Sheet Daily

Executive Summary

Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.

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