Regulatory Affairs 101: Introduction to Expedited Regulatory Pathways

Cox, EM; Edmund, AV; Kratz, E; Lockwood, SH; Shankar, A

Kratz, E (corresponding author), Denali Therapeut Inc, San Francisco, CA 94080 USA.

CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2020; 13 (3): 451

Abstract

Developing a novel drug, including discovery, nonclinical toxicology studies, initial clinical trials, and thorough pivotal studies, may take many yea......

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