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Regulation Drug Review Approvals

Eteplirsen Review Offers Lessons For FDA, Advocacy Groups, Industry

  • Analysis

Executive Summary

Agency reviewers believed the line between patient input and external intimidation had been crossed; early data from the Sarepta muscular dystrophy drug's flawed development program stoked patient community expectations and made regulatory review difficult.

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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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