Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development

On 2 May 2022 the FDA announced the availability of the draft guidance for industry.

This draft guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage setting.

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