SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility

Campbell, UB; Honig, N; Gatto, NM

Campbell, UB (通讯作者),Aetion Inc, New York, NY 10001 USA.;Campbell, UB (通讯作者),Columbia Mailman Sch Publ Hlth, New York, NY 10032 USA.

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 114 (5): 981

Abstract

Based on recent guidance and publicly available approvals, the US Food and Drug Administration (FDA) has demonstrated its openness to considering evid......

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