Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.

Shahzad, Mahnum; Naci, Huseyin; Wagner, Anita K

Shahzad, Mahnum; Naci, Huseyin; Wagner, Anita K.

Afiliação

Shahzad M; Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Naci H; Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.
Wagner AK; Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.

JAMA ; 329(9): 760-761, 2023 03 07.

Article em En | MEDLINE | ID: mdl-36705931

This study examines the Food and Drug Administration's accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.

Assuntos

Aprovação de Drogas; United States Food and Drug Administration; Aprovação de Drogas/métodos; Estados Unidos

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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 Tipo de estudo: Risk_factors_studies País/Região como assunto: America do norte Idioma: En Revista: JAMA Ano de publicação: 2023 Tipo de documento: Article

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