# E16 Biomarkers Related to Drug or Biotechnology Product Development:  Context, Structure, and Format of Qualification Submissions - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e16-biomarkers-related-to-drug-or-biotechnology-product-development-context-structure-and-format-of-qualification-submissions/dff4ff01-57a3-4145-a118-925a3a80b83c

> FDA guidance document: E16 Biomarkers Related to Drug or Biotechnology Product Development:  Context, Structure, and Format of Qualification Submissions. Issue date: August 11, 2011. Get complete insights and analysis.

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## Details

- Title: E16 Biomarkers Related to Drug or Biotechnology Product Development:  Context, Structure, and Format of Qualification Submissions
- 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: 2011-08-11
- Last Changed: 2020-04-20
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2009-D-0324">FDA-2009-D-0324</a>

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