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Reference 8 - Expectations for Biodistribution BD Assessments for Gene Therapy GT Products…

Supporting & Related Material · FDA-2020-D-2101 · posted May 17, 2022

Key facts

Document ID FDA-2020-D-2101-0033
Title Reference 8 - Expectations for Biodistribution BD Assessments for Gene Therapy GT Products International Pharmaceutical Regulators Programme IPRP Reflection Paper re Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2020-D-2101
Posted May 17, 2022

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