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Drug Approval Standards Rare Diseases Regulation

US FDA's New Drug Assessors More Experienced With Rare Disease Issues

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Executive Summary

Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.

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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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