Remove Assay Development Remove FDA Approval Remove Treatment Remove Workshop
article thumbnail

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. Like ORR, FDA considers PFS to be an appropriate surrogate endpoint for accelerated approval, traditional approval, and for measuring direct clinical benefits in certain circumstances.

FDA 40