Pathways for Using Biomarkers in Drug Development

Описание к видео Pathways for Using Biomarkers in Drug Development

Dr. Chris Leptak of the FDA’s Center for Drug Evaluation and Research discusses the three primary sources for biomarker evidence use by FDA to inform regulatory decisions – scientific community consensus, drug-specific development and approval process, and CDER’s Biomarker Qualification Program. No matter which pathway the drug developer selects, consulting with the FDA is a critical step to achieve success.

Learn more about FDA’s biomarker qualification program at http://www.fda.gov/biomarkerqualifica...

Комментарии

Информация по комментариям в разработке

Похожие видео