Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration | Zendy

Kuo Jiao | Zendy; Ravi Gupta | Zendy; Erin R. Fox | Zendy; Aaron S. Kesselheim | Zendy; Joseph S. Ross | Zendy

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Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration

Author(s) -

Kuo Jiao,

Ravi Gupta,

Erin R. Fox,

Aaron S. Kesselheim,

Joseph S. Ross

Publication year - 2019

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2019.13029

Subject(s) - food and drug administration , economic shortage , drug , competition (biology) , administration (probate law) , new drug application , drug administration , business , medicine , pharmacology , risk analysis (engineering) , political science , ecology , linguistics , philosophy , government (linguistics) , law , biology

This cross-sectional study describes the characteristics of abbreviated new drug applications approved by the US Food and Drug Administration, focusing on those with limited generic competition or with history of shortages.

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