Presentation | January 25, 2016

Confused By FDA Guidance On Standardized Study Data For Electronic Submissions?

Source: Rho
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The FDASIA 745(a) guidance requires certain that INDs, NDAs, ANDAs, and certain BLAs be submitted electronically during drug development. As this guidance is binding and failure to follow its technical conformance rules will result in a refusal to file, it’s important to understand it. For information on the standardized data format and how it can impact your organization, download the power point presentation.