This Document is incorporated by reference into the following Guidance Document(s):
Guidance for Industry Providing Regulatory Submissions in Electronic
SEPTEMBER 2024
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. 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.
FDA GUIDANCE: STUDY DATA TECHNICAL CONFORMANCE GUIDE
Technical Specifications Document