Global regulatory progress in delivering on the promise of gene therapies for unmet medical needs.

Drago, Daniela; Foss-Campbell, Betsy; Wonnacott, Keith; Barrett, David; Ndu, Adora

Drago, Daniela; Foss-Campbell, Betsy; Wonnacott, Keith; Barrett, David; Ndu, Adora.

Afiliação

Drago D; Biogen, Inc., Global Safety and Regulatory Sciences, Cambridge, MA, USA.
Foss-Campbell B; American Society of Gene and Cell Therapy, Policy and Advocacy, Milwaukee, WI, USA.
Wonnacott K; Pfizer, Inc., Global Regulatory Affairs, Gaithersburg, MD, USA.
Barrett D; American Society of Gene and Cell Therapy, Executive Office, Milwaukee, WI, USA.
Ndu A; BioMarin Pharmaceutical, Inc., Worldwide Research and Development Strategy, Scientific Collaborations and Policy, Washington, DC, USA.

Mol Ther Methods Clin Dev ; 21: 524-529, 2021 Jun 11.

Article em En | MEDLINE | ID: mdl-33997101

Palavras-chave

Advanced Therapies; Convergence; European Medicines Agency; Food and Drug Administration; Gene Therapy; Global Development; Recognition; Regenerative Medicine; Regulation; Regulatory Pathways; Reliance; Work Sharing

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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2021 Tipo de documento: Article

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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2021 Tipo de documento: Article