Regulations.gov document

Reference 3 - Chemistry, Manufacturing, and Control (CMC) Information for Human Gene…

Supporting & Related Material · FDA-2018-D-2238 · posted Jan 30, 2020

Key facts

Document ID FDA-2018-D-2238-0039
Title Reference 3 - Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications IND Guidance for Industry re Human Gene Therapy for Hemophilia; Guidance for Industry
Document type Supporting & Related Material
Subtype Background Material
Agency FDA
Docket FDA-2018-D-2238
Posted Jan 30, 2020

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