Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US.

Tajima, Gentaro; Huh, Seoan; Schmidt, Natalie Anne; Macdonald, Judith C; Fleischmann, Tobias; Wonnacott, Keith Merrell

Tajima, Gentaro; Huh, Seoan; Schmidt, Natalie Anne; Macdonald, Judith C; Fleischmann, Tobias; Wonnacott, Keith Merrell.

Afiliação

Tajima G; Pfizer R&D Japan G.K., Regulatory Affairs, Shibuya-ku, 3-22-7, Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
Huh S; Pfizer, Inc., Global Regulatory Affairs, Lake Forest, IL, USA.
Schmidt NA; Pfizer R&D, Ltd., Global Regulatory Affairs, Walton, Oaks, UK.
Macdonald JC; Pfizer R&D, Ltd., Global Regulatory Policy, Walton, Oaks, UK.
Fleischmann T; Pfizer Pharma, GmbH, Biotransformation and Environmental Sciences, Germany.
Wonnacott KM; Pfizer, Inc., Global Regulatory Affairs, Gaithersburg, MD, USA.

Mol Ther Methods Clin Dev ; 26: 74-83, 2022 Sep 08.

Article em En | MEDLINE | ID: mdl-35782596

Palavras-chave

European Medicines Agency; Ministry of Health, Labour and Welfare; Pharmaceuticals and Medical Devices Agency; U.S. Food and Drug Administration; adeno-associated virus; environmental risk assessment; genetically modified organisms; multi-regional clinical trials; viral shedding; virus vectors

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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Risk_factors_studies Idioma: En Revista: Mol Ther Methods Clin Dev Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Japão

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