Author: priyanegi

The FDA released the Evidentiary Framework Drafts Guidance for biomarker validation and testing in December 2018. Purpose of the Evidentiary Framework Biomarker testing and validation in the drug development process is an essential and crucial tool for the decision-making process. However, these biomarkers were initially process-specific, and there was no prescribed regulatory process to ascertain the broader use of these biomarker assays for programs apart from the specific drug programs they were used for. This guidance aims to cover the regulatory gap observed in terms of the extended use of biomarkers beyond specific programs. Biomarker validation and testing aren’t just…

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