2023, Assay Development, DNA and FDA Approval

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2023

Assay Development

DNA

FDA Approval

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 Treatment DNA

The path to improved safety of gene-based products

Drug Discovery World

MAY 11, 2023

In addition, their cumbersome developmental process limits their use for fast-tracked new modalities, such as DNA-based vaccines. This approval could pave the way for LC-MS to transition more frequently into a good manufacturing process (GMP) environment, where it can be used as a release assay for regulatory documentation.

Production

Production Vaccine Immune Response Therapies

Drug Discovery Digest

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

The path to improved safety of gene-based products

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