Living cells — highest scrutiny
Biologic — Cellular
Living cells. Usually a section 351 biologic needing an approved BLA or an active IND.
No patient needed
- 1What it is
- 2Who makes it
- 3Fit for your practice
- 4Products
- 5Build your order
What it is
Products containing living cells. These are the most likely to be regulated as section 351 biologics requiring an approved Biologics License Application, and the least likely to qualify for the 361 HCT/P exemption.
Patient named before it is madeNo