The US Food and Drug Administration has proposed a guidance that would update its policy on how sponsors can provide information on potency assurance for cell and gene therapy (CGT) products. If finalized, it would update a previous guidance that was less broad and focused on testing, which the agency acknowledged can be burdensome.
On 28 December 2023, FDA published a draft guidance on potency assurance for CGT products that the agency says takes a risk-based total product lifecycle (TPLC) approach. When finalized, the guidance is meant to replace a 2011 final guidance on potency tests for CGT products…
