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USFDA Guidance: Bioanalytical Method Validation for Biomarkers
On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...
Sharan Murugan
Jan 212 min read
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USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...
Sharan Murugan
Nov 4, 20221 min read
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