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Keeping Track: US FDA Refuses To File Acorda, SteadyMed NDAs

Executive Summary

Issues involving inspectional readiness and the drug master production record cited in agency's refusal to review Acorda's Inbrija in Parkinson's disease; SteadyMed faces request for additional design verification and validation testing for drug/device combo Trevyent in pulmonary arterial hypertension.

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