Data Concepts and Terminology Standards for the Support of Human Drug Development and Evaluation

The Center for Drug Evaluation and Research (CDER) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. This wealth of data holds great potential to advance CDER’s regulatory and scientific work, but the present lack of standardized data creates significant challenges to realizing that potential.The volume and complexity of drug-related information submitted to CDER for regulatory review is creating significant challenges to the Center’s ability to efficiently and effectively perform its critical public health mission.The lack of standardized data affects CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. Improved data quality, accessibility and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions and address late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center’s performance across key drug regulatory functions and ongoing business operations, including pre-market review, post-market safety, oversight of drug quality, and oversight of drug promotion.In accordance with the Office of Management and Budget (OMB) Circular A-119, the FDA will: use voluntary, consensus-based standards development processes in place of government unique standards unless such standards are inconsistent with law or otherwise impractical; advocate to align these standards with existing health information technology initiatives, laws, regulations, and mandates; and promote coordination with other standards currently in use. The projects selected under this funding opportunity must adhere to these principles.