Study Data Technical Conformance Guide – Technical Specifications Document

1 May 2023 – the FDA published final guidance on the study data on technical conformance for the electronic submission.

This Guide provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards.

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