Links to major regulatory information of Biostatistics.
Regulations and Notifications
Clinical Trial Design
- Statistical Considerations When Planning Phase I Clinical Trials in Oncology - From the Safety Perspective (Early consideration) [197KB]
December 4, 2024 Office of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency
Master Protocol
June 20, 2024 Administrative Notice
Data Monitoring
April 4, 2013 PFSB/ELD Notification No. 0404-1