What Do You Need to Consider When Qualifying a Biomarker?

Описание к видео What Do You Need to Consider When Qualifying a Biomarker?

Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), discusses the development of criteria for biomarker qualification and how the proposed use of a biomarker affects the level of evidence needed.

Learn more about FDA’s Biomarker Qualification Program at https://www.fda.gov/Drugs/Development...

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