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

Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans: French HTML file. From Health Canada, updated Jun 2021. View metadata, licence and the direct download on CanQuery.

Format

HTML

Access

Original download only

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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