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

Jiao, Kuo; Gupta, Ravi; Fox, Erin; Kesselheim, Aaron; Ross, Joseph S · JAMA Netw Open · 2019

cross_sectional · Level IV

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Abstract

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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