FDA Law Blog: Drug Discovery

JANUARY 4, 2023

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

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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.

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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. It’s not necessarily just the assays themselves that need to be standardized, but when and how they are being used by clinicians.

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