Will REMS Delay Generics? Revlimid Petition May Help Determine The Answer
This article was originally published in The Pink Sheet Daily
Executive Summary
Dr. Reddy’s asks FDA to spell out policy to assure that new Risk Evaluation and Mitigation Strategies will be used to block generics. Celgene’s refusal to make Revlimid available for bioequivalence study is at issue.
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