The Biomarker Qualification Process: A Roadmap for Requestors
Автор: U.S. Food and Drug Administration
Загружено: 2017-09-15
Просмотров: 3029
Описание:
Marianne Noone, RN, from FDA’s Center for Drug Evaluation and Research (CDER), describes the biomarker qualification process and the submission roadmap for biomarker qualification requestors. The process for biomarker qualification was modified in response to the 21st Century Cures Act passed in 2016. This module is an introductory guide through the updated process, which contains three submission stages: the Letter of Intent, the Qualification Plan, and the Full Qualification Package.
Learn more about FDA’s Biomarker Qualification Program at http://www.fda.gov/biomarkerqualifica....
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