As FDA Data Standardization Looms, CDISC Looks to Transition to More Frequent Changes

November 14, 2016

With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements, and is considering developing more frequent and granular updates to those standards in the future.

The standards and templates provided by the Clinical Data Interchange Standards Consortium (CDISC) detail the technical formatting and organization of clinical study data.  The FDA’s Data Standards Catalog lists several different formats that can be used by industry in their submissions, including CDISC’s Study Data Tabulation Model or the Standard for Exchange of Nonclinical Data.

For studies that begin after Dec. 17, CDER and CBER may refuse to accept NDAs, BLAs and ANDAs whose data does not conform to CDIS’s standards, the FDA said.

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