Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Fan, M; Chan, AYL; Yan, VKC; Tong, XN; Lau, LKW; Wan, EYF; Tam, EYT; Ip, P; Lum, TY; Wong, ICK; Li, X

Li, X (通讯作者)，Univ Hong Kong, Ctr Safe Medicat Practice & Res, Dept Pharmacol & Pharm, Li Ka Shing Fac Med,Pokfulam, L2-59,2-F,Lab Block,Fac Med Bldg,21 Sassoon Rd, Hong Kong, Peoples R China.;Li, X (通讯作者)，Hong Kong Sci Pk, Lab Data Discovery Hlth D24H, Sha Tin, Hong Kong, Peoples R China.;Li, X (通讯作者)，Univ Hong Kong, Li Ka Shing Fac Med, Dept Med, Pokfulam, Hong Kong, Peoples R China.

ORPHANET JOURNAL OF RARE DISEASES, 2022; 17 (1):

Abstract

Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketi......

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