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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 study data using FDA-supported1 data standards located in the FDA Data Standards Catalogue.

The Guide supplements the guidance for Industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data (eStudy Data).

This Guide provides technical recommendations to sponsors4 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

On August 16, 2021, FDA updated the technical specifications document “Study Data Technical Conformance Guide.” which addresses the pilot and failed studies submitted to ANDAs, which the Agency does not expect to comply with FDA’s standardized study data requirements as of September 15, 2021, in order to facilitate the submission of these specific studies to ANDAs.

Sponsors/applicants submitting applications as of September 15, 2021, must identify pilot and failed studies submitted to ANDAs as recommended in the “Study Data Technical Conformance Guide” to ensure that their submission is not rejected based on improperly identified studies.

On September 15, 2021, the Food & Drug Administration (FDA) will commence rejecting submissions subject to section 745A(a) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (ANDAs, NDAs, certain BLAs, and certain INDs) that fail to pass high validation errors included in the “Technical Rejection Criteria for Study Data” (TRC), which are used to determine compliance with the requirement to submit electronic standardized study data.

Compliance with these standards established under section 745A(a) of the FD&C Act is necessary to ensure the consistent organization of data to facilitate submission review.



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