Lexology April 29, 2024
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CBER and CDER issue update to their Study Data Technical Conformance Guide.
- CBER and CDER released a March 2024 update to their document entitled, “Study Data Technical Conformance Guide – Technical Specifications Document.” This document is incorporated by reference into the guidance document entitled, “Guidance for Industry Providing Regulatory Submissions in Electronic Format – Standardized Study Data.”
- This conformance guide provides technical recommendations to sponsors for the submission of animal and human study data in a standardized electronic format to CBER and CDER. Updates in this most recent version include new specifications for information contained...
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