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FDA Guidances & Rules
In this section:
FDA Data Standards Advisory Board
Official FDA Source
Study Data Standards Resources
Official FDA Source
FDA Data Standards Advisory Board
Official FDA Source
FDA Data Standards Advisory Board
Official FDA Source
Study Data Standards Resources
Official FDA Source
eCTD Resources
Official FDA Source
Data Standards Catalog
Official FDA Source
Study Data Technical Conformance Guide
Official FDA Source
(eCTD) - Providing Submissions in Electronic Format using the eCTD Specifications
Official FDA Source
(eCTD) - Submission Standards for eCTD v3.2.2 and Regional M1
Official FDA Source
(eCTD) - Submission Standards for eCTD v4.0 and Regional M1
Official FDA Source
(RWD) - Data Standards for Drug and Biological Product Submissions Containing Real-World Data
Official FDA Source
(sdTCG) - Study Data Technical Conformance Guide
Official FDA Source
(BIMO TCG) - Bioresearch Monitoring Technical Conformance Guide
Official FDA Source
(ICSR TCG) - Electronic Submissions of IND Safety Reports Technical Conformance Guide
Official FDA Source