Module 12 2019

Legal Basis - Federal Register 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). The regulations require that CSD be submitted for NDAs, BLAs and ANDAs and their 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