A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA's Benefit-Risk Framework.

Mutanga, Jane Namangolwa; Nukala, Ujwani; Rodriguez Messan, Marisabel; Yogurtcu, Osman N; McCormick, Quinn; Sauna, Zuben E; Whitaker, Barbee I; Forshee, Richard A; Yang, Hong

Mutanga, Jane Namangolwa; Nukala, Ujwani; Rodriguez Messan, Marisabel; Yogurtcu, Osman N; McCormick, Quinn; Sauna, Zuben E; Whitaker, Barbee I; Forshee, Richard A; Yang, Hong.

Afiliación

Mutanga JN; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Nukala U; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Rodriguez Messan M; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Yogurtcu ON; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
McCormick Q; Office of Therapeutic Products, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Sauna ZE; Office of Therapeutic Products, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Whitaker BI; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Forshee RA; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA.
Yang H; Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US FDA, Silver Spring, Maryland, USA. Hong.Yang@fda.hhs.gov.

AAPS J ; 25(1): 24, 2023 02 09.

Article en En | MEDLINE | ID: mdl-36759415

Asunto(s)

Comités Consultivos; Productos Biológicos; Estados Unidos; Estudios Retrospectivos; Gestión de Riesgos; Incertidumbre; United States Food and Drug Administration

Palabras clave

US Food and Drug Administration; advisory committees; benefit-risk; biological products; risk management

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Productos Biológicos / Comités Consultivos Tipo de estudio: Etiology_studies / Guideline / Observational_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies País/Región como asunto: America do norte Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

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