Module 12 Presentations

26/01/2024

US Requirements for Clinical Data The Food and Drug Administration amended the regulations governing the format in which clinical study data (CSD) are required to be submitted for new drug applications (NDAs), biological license applications (BLAs) and abbreviated new drug applications (ANDAs) AND Commercial INDs. The regulations require that CSD be submitted for NDAs, BLAs, ANDAs and INDs including supplements and amendments be provided in an electronic format that FDA can process, review, and archive. The proposal requires the use of standardized data structure, terminology, and code sets to allow for more efficient and comprehensive review of CSD.

The Organisation for Professionals in Regulatory Affairs

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• Supplements the guidance for industry Providing Regulatory Submissions in Electronic Format Study Data Technical Conformance Guide • Provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog — Standardized Study Data (eStudy Data – July 2021)

The Organisation for Professionals in Regulatory Affairs

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