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Sharan Murugan
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...
260
Sharan Murugan
Nov 32 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
130
Sharan Murugan
Nov 32 min read
Australia's TGA Good Clinical Practice (GCP) Inspection Program
Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...
220