# Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/biomarker-qualification-evidentiary-framework-draft-guidance-for-industry-and-fda-staff/c198796d-4230-4499-a6ee-2f84eed424c9

> FDA guidance document: Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff. Issue date: December 12, 2018. Get complete insights and analysis.

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## Details

- Title: Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2018-12-12
- Comment Close Date: 2019-02-11
- Last Changed: 2020-05-07
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-4267">FDA-2018-D-4267</a>

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