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BioPharmaceutical United States Drug Approval Standards

Accelerated Approval Legislation Picking Up Speed; ULTRA Becoming FAST

This article was originally published in The Pink Sheet Daily

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Executive Summary

Revisions to the House bill make it nearly identical to sections of Sen. Kay Hagan’s legislation. The debate on PDUFA add-ons will be rejoined at a Commerce Committee hearing, but TREAT now has considerable momentum.

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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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