Flexibility in the FDA approach to orphan drug development

Hunter, NL; Rao, GR; Sherman, RE

Hunter, NL (reprint author), US FDA, Off Commissioner, 10903 New Hampshire Ave, Silver Spring, MD 20993 USA.

NATURE REVIEWS DRUG DISCOVERY, 2017; 16 (11): 737

Abstract

Scientific advances, in combination with government incentives and commercial opportunity, have fuelled strong investment in orphan drugs, resulting i......

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