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Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER

Executive Summary

US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.

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