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US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

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  • Analysis
By Bridget Silverman

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Complete Response Letters Drug Approval Standards
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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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