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Pharmaceuticals / Inspections and Audits

FDA Announces Timetable for Updates to Data Standards Catalog for Electronic Study Data

Jan. 26, 2018
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The FDA issued a notice on its timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in new drug applications, abbreviated new drug applications, biologics license applications, and certain investigational new drugs.

The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after publication of the final guidance ‘‘Providing Regulatory Submissions in Electronic Format—Standardized Study’’ in December 2014.

When future updates to study data standards listed in the FDA Data Standards Catalog occur, the updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates, the agency said. When future new study data standards are listed in the Catalog, the new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing the new standards.

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