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Drug Approval Standards Drug Safety FDA

The New Zelnorm-al (Part 2): More Thoughts On The Revival Of The 5HT4 Class

  • Analysis

Executive Summary

Looming return of Zelnorm to US market is milestone event for current regulatory climate. But FDA’s hands-on work to resurrect a different 5HT4 agonist, prucalopride, probably says more about what is truly different about the agency today.
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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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