Assay Development, DNA and Workshop - Drug Discovery Digest

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Assay Development

DNA

Workshop

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

Agency IQ

JULY 21, 2023

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. As dying cancer cells degrade, their cell contents are released into the patient’s circulation, affording the possibility of detecting fragments of DNA that are unique to the cancer.

FDA

FDA Clinical Trials DNA Treatment

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

Although this requirement is not new, EMA highlights the pathway for qualification of novel methodologies that could result in a letter of support to aid further development or full qualification, which then supports the acceptability of the method for its intended purpose.

Clinical Trials

Clinical Trials Trials Treatment Production

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

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

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