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Guidance Documents/Compliance-Policy-Guide-Cpg/CPG Sec 280100 - Stability Requirements - Licensed In Vitro Diagnostic Products

CPG Sec 280100 - Stability Requirements - Licensed In Vitro Diagnostic Products

Detailed guidance document from FDA and regulatory agencies.

Document Details

Compliance Policy Guide (CPG)

July 31, 2020

November 5, 2024

Center for Biologics Evaluation and Research

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