Regulatory Aspects of Gene Therapy: The Regulatory Life Cycle.

Animals Child Drug Approval Genetic Therapy Humans Life Cycle Stages United States United States Food and Drug Administration
Cell therapy Food and drug administration (FDA) Gene therapy Pediatric Regulations

Journal

Hematology/oncology clinics of North America
ISSN: 1558-1977
Titre abrégé: Hematol Oncol Clin North Am
Pays: United States
ID NLM: 8709473

Informations de publication

Date de publication:
08 2022
Historique:
pubmed: 1 7 2022
medline: 20 7 2022
entrez: 30 6 2022
Statut: ppublish

Résumé

The recent progress in gene and gene-modified cellular therapies has shown great promise for numerous pediatric diseases. Nevertheless, the development of these products is complicated, and the regulatory pathway is rigorous. There are, however, several opportunities for programmatic support within the Food and Drug Administration. This article highlights the life cycle of product development through approval and many of the available resources and programs to support product development.

Identifiants

DOI: 10.1016/j.hoc.2022.03.004 PMID: 35773050
pubmed: 35773050
pii: S0889-8588(22)00025-9
doi: 10.1016/j.hoc.2022.03.004
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

687-699

Informations de copyright

Copyright © 2022 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure The authors have nothing to disclose.

Auteurs

Najat 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.

Megha 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.

Poornima 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.

Kristin 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.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Sciences sociales › Sociologie › Agrément de médicaments › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Génie génétique › Thérapie génétique › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Phénomènes physiologiques › Croissance et développement › Morphogenèse › Métamorphose biologique › Étapes du cycle de vie › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Regulatory Aspects of Gene Therapy: The...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Regulatory Aspects of Gene Therapy: The...