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Generic Drugs Review Pathway Regulation

For ANDAs, Pre-Submission Facility Correspondence Has Improved, But Still Not Ideal

  • Analysis

Executive Summary

US FDA wants the program, intended to help speed ANDA approvals, utilized more, but industry still questions the information that must be submitted.

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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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