United States:
FDA Releases Study Data Technical Conformance Guide Version 2.0, Updates Catalog
03 February 2015
Jones Day
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In the January 12, 2015, Federal Register,
FDA announced the availability of a Study Data Technical
Conformance Guide, Version 2.0 ("Guide"), and an update
to the Data Standards Catalog. The Guide supplements Guidance for Industry: Providing Regulatory
Submissions in Electronic Format—Standardized Study
Data.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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