Overview of FDA Drug Approval and Labeling.

Clarridge, Katherine E; Chin, Stacy J; Stone, Kelly D

Clarridge, Katherine E; Chin, Stacy J; Stone, Kelly D.

Afiliação

Clarridge KE; Division of Pulmonology, Allergy, and Critical Care, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Md. Electronic address: Katherine.Clarridge@fda.hhs.gov.
Chin SJ; Division of Pulmonology, Allergy, and Critical Care, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Md.
Stone KD; Division of Pulmonology, Allergy, and Critical Care, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Md.

J Allergy Clin Immunol Pract ; 10(12): 3051-3056, 2022 12.

Article em En | MEDLINE | ID: mdl-36496207

Assuntos

Aprovação de Drogas; Uso Off-Label; Estados Unidos; Humanos; United States Food and Drug Administration; Rotulagem de Medicamentos; Rotulagem de Produtos

Palavras-chave

Drug; Drug regulation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aprovação de Drogas / Uso Off-Label Tipo de estudo: Risk_factors_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article

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