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BioPharmaceutical

Playing Nice Over REMS: FDA Sees Accutane As Model For Shared Systems

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Executive Summary

FDA will use the Accutane risk management agreement between Roche and generic drug companies as a guide for implementing the Risk Evaluation & Mitigation Strategy "shared use" provision of the FDA Amendments Act
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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