Question 1: Name of Product
The name of the product reported will be auto populated from what was reported on the Pre-TED (F2400) form.
Questions 2 – 5: Specify the identifier(s) associated with this gene therapy product (check all that apply)
Indicate the identifiers (Product ID, Batch Number, or Lot Number) associated with this gene therapy product. At least one identifier should be reported. Check all that apply.
- Gene therapy product ID: Product IDs can be numeric or alphanumeric and are found with the product bag or shipping manifest.
- Batch number: Batch numbers can be numeric or alphanumeric and are available with the information that comes with the product
- Lot number: Lot numbers can be numeric or alphanumeric and are available with the information that comes with the product
Section Updates:
Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
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Last modified:
Oct 23, 2023
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