FDA Adopts New Data Standard for Regulatory Submissions

The FDA is updating the technical standard required for sponsors to submit investigational study data as part of an application to the Center for Drug Evaluation and Research.

The new standard is version 1.1 of the Clinical Data Interchange Standards Consortium’s analysis data model implementation guide (ADaM IG V1.1). It replaces ADaM IG V1.0.

The agency is encouraging sponsors to use ADaM IG V1.1 now, and will require it after March 15, 2019.