Regulatory Aspects of Gene Therapy: The Regulatory Life Cycle.

Bouchkouj, Najat; Kaushal, Megha; Sharma, Poornima; Baird, Kristin

Bouchkouj, Najat; Kaushal, Megha; Sharma, Poornima; Baird, Kristin.

Afiliación

Bouchkouj N; Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO71, Silver Spring, MD 20993, USA. Electronic address: Najat.Bouchkouj@fda.hhs.gov.
Kaushal M; Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO71, Silver Spring, MD 20993, USA.
Sharma P; Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO71, Silver Spring, MD 20993, USA.
Baird K; Office of Tissue and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, WO71, Silver Spring, MD 20993, USA.

Hematol Oncol Clin North Am ; 36(4): 687-699, 2022 08.

Article en En | MEDLINE | ID: mdl-35773050

Asunto(s)

Aprobación de Drogas; Terapia Genética; Animales; Niño; Humanos; Estadios del Ciclo de Vida; Estados Unidos; United States Food and Drug Administration

Palabras clave

Cell therapy; Food and drug administration (FDA); Gene therapy; Pediatric; Regulations

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Terapia Genética / Aprobación de Drogas Límite: Animals / Child / Humans País/Región como asunto: America do norte Idioma: En Revista: Hematol Oncol Clin North Am Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2022 Tipo del documento: Article

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