1. Administrative documents
Administrative documents (e.g., application forms, cover letters, reviewer guides), and labeling information should be submitted. The cover letter should include a brief explanation of the submission and its contents. When amendments are submitted to the clinical trial application for manufacturing changes, the cover letter should clearly describe the purpose of the amendment and highlight proposed changes.
2. Labels
The clinical trial application, must contain a copy of all labels and labeling to be provided to each investigator in the clinical study. It is recommended to include sample or mock-up labels in the administrative section of the application. The applicants should note that investigational products must bear a label indicating that it is for “investigational use only”. Other important labeling information such as those
- For products derived from autologous sources the statement: “FOR AUTOLOGOUS USE ONLY”, should be used. And,
- If donor testing and screening is not performed, the product should be labeled “NOT EVALUATED FOR INFECTIOUS SUBSTANCES”
3. Previously Submitted Information
Should the applicant wish to cross reference another product, the applicant is required to submit a written statement in the clinical trial application that appropriately identifies information previously submitted. The applicant should describe the information and identify where that information is located in the previously submitted file.