Page History

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SEND at FDA - with timing and information of usage at various FDA divisions (CDER, CVM, CBER, etc.)

FDA-2014-D-0092: and CatalogGuidance: -2012-D-0097:FDA-2014-D-0085:Guidance:

Registry Notice: FR02-06 - 2014-02553.pdf

Common Resources in the SEND World
CDISC/SEND Links
CDISC SEND - This page has links to the SEND Implementation Guide and Controlled Terminology SEND Implementation News - For updates in the SEND world SEND Implementation Forum - For asking questions about SEND Implementation
FDA Links
FDA Study Data Standards Resources - with various resource links Study Data Standards for Submission to CDER - with some additional information related to submissions to CDER
FDA Draft Guidances and Federal Registry Notices for Electronic Submissions
FDA Newly Added Guidance Documents FDA	Study Data Technical Conformance Guide	- see FDA Study Data Standards	Resources for most up-to-date link FDA	Data Standards Catalog - see FDA Study Data Standards Resources for most up-to-date link	Providing Regulatory Submissions in Electronic Format - Standardized Study Data	(Most recent Guidance and Register Notice linked from here) - aka Docket FDA-2012-D-0097	Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act	(Most recent Guidance and Register Notice linked from here) - aka FDA-2014-	D-0085

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