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Reference 4 - Q5E Comparability of Biotechnological Biological Products Subject to Changes…

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

Key facts

Document ID FDA-2020-D-2101-0029
Title Reference 4 - Q5E Comparability of Biotechnological Biological Products Subject to Changes in Their Manufacturing Process Guidance for Industry re Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry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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