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Nov 92 min read

USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

The Study Data Technical Conformance Guide (SDTCG) from the USFDA provides a framework to help sponsors submit standardized study data...

May 25, 20232 min read

USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...

Sep 14, 20212 min read

USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA

Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...