The Use of External Controls in FDA Regulatory Decision Making

Jahanshahi, M; Gregg, K; Davis, G; Ndu, A; Miller, V; Vockley, J; Ollivier, C; Franolic, T; Sakai, S

Jahanshahi, M (corresponding author), BioMarin Pharmaceut Inc, 105 Digital Dr, Novato, CA 94949 USA.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021; 55 (5): 1019

Abstract

The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-......

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