2017 Is Banner Year for Drug Approvals by the Food and Drug Administration.

Ebied, Alex M; Cooper-DeHoff, Rhonda M

Ebied, Alex M; Cooper-DeHoff, Rhonda M.

Afiliação

Ebied AM; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Fla. Electronic address: ebiedrx55@ufl.edu.
Cooper-DeHoff RM; Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, Fla.

Am J Med ; 131(9): 1025-1033, 2018 09.

Article em En | MEDLINE | ID: mdl-29626430

ABSTRACT

ABSTRACT

In 2017, the US Food and Drug Administration approved 46 novel drugs, and 29 drugs received newly approved indications. This record setting year was due in part to the new expedited review pathways. A review of these drugs is summarized.

Assuntos

Aprovação de Drogas/estatística & dados numéricos; United States Food and Drug Administration; Humanos; Estados Unidos

Palavras-chave

Accelerated approval; FDA; Fast track; New indication; Novel drugs; Priority review

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: United States Food and Drug Administration / Aprovação de Drogas Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Am J Med Ano de publicação: 2018 Tipo de documento: Article

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