@irenekwshiu - for some reason I can't reply to you (using the reply button under your post)
As is clear from the below draft FDA guidance published in late September 2023 on potency tests for cell and gene therapy products, it’s the drug developer or sponsor’s job, not that of the FDA, to demonstrate the validity of the potency assay test(s) - see p.14 of https://www.fda.gov/files/vaccines,%20blood%20%26%20biologics/published/Final-Guidance-for-Industry--Potency-Tests-for-Cellular-and-Gene-Therapy-Products.pdf
Irene, I respect that you have posted some links previously including this one above that shows you are trying to research. Something in your post suggested you thought I was overlooking what you said.
Without going to your link I believe what you are saying above in bold is true in so far as it goes - but I put a simple question to you - even though its not the FDA's responsibility to do the work of demonstrating the validity of any potency assays -that's as you say the drug developer or sponsors job - to whom do you think that validation work is submitted if not the FDA? Who if not the FDA has the most decisive and impactful opinion on whether the validation offered is a success or not?
I can't see any way in which you couldn't conclude that of course the FDA must themselves also form an opinion on whether or not any offered to them as validated potency assay has in fact in their view been validated by the evidence, methods and arguments present by the sponsor.
MSB Price at posting:
$1.47 Sentiment: None Disclosure: Not Held
(20min delay)