Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans (French, HTML)

View metadata and access the original French HTML file: Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans.

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HTML

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Publisher-reported update

2021-06-02

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.

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