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Generic Drugs FDA Regulation

Competitive Generic Therapy Designations Growing Despite Lack Of Guidance

  • Analysis

Executive Summary

US FDA developing document describing program operations, but that has not stopped sponsors from requesting and receiving the breakthrough-like designation. 

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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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