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USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...

Sharan Murugan
Apr 27, 20253 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...

Sharan Murugan
Nov 9, 20242 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...

Sharan Murugan
May 25, 20232 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...

Sharan Murugan
Sep 14, 20212 min read
