# Study Data Technical Conformance Guide - Technical Specifications Document - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/study-data-technical-conformance-guide-technical-specifications-document/209e707c-4233-4a8a-93fd-f9203eff2aff

> FDA guidance document: Study Data Technical Conformance Guide - Technical Specifications Document. Issue date: December 16, 2025. Get complete insights and analysis.

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## Details

- Title: Study Data Technical Conformance Guide - Technical Specifications Document
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-12-16
- Comment Close Date: 2014-05-07
- Last Changed: 2025-12-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-0092">FDA-2014-D-0092</a>

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