Prescription Drug User Fee Act (PDUFA) > PDUFA Information Technology Plans

Data Standardization Initiatives

FDA houses a vast repository of all clinical trials data submitted for regulatory review by sponsors. The major challenge to the electronic pooling of data across studies is the lack of consistent data standards. OWH is supporting FDA efforts to standardize clinical trials data into CDISC format to facilitate demographic and sex analyses for participation and outcome differences within and across regulatory submissions. OWH is also supporting pilot projects conducted by FDA Centers to convert legacy data to the CDISC format on some drug and biologics applications.

To Learn More:

►FDA Resources for Data Standards
FDA Resources for Data Standards

►CDER Data Standards Plan
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf

► Prescription Drug User Fee Act (PDUFA) Information Technology Plans
Prescription Drug User Fee Act (PDUFA) > PDUFA Information Technology Plans