Biomedical Informatics and Regulatory Review Science (BIRRS)
BIRRS is a multidisciplinary team of clinical and data experts that develops novel tools and approaches to regulatory review activities across OND, as well as standardizes review approaches. The team supports OND-wide initiatives that bridge clinical expertise, informatics, and best practices for analyses and interpretation of diverse data. The BIRRS team leverages subject matter expertise along with analytic and machine learning methodologies to advance their work. The team also collaborates with external stakeholders (e.g., PHUSE, ICH) to harmonize clinical trial reporting and analyses.
Our work includes:
- Standard Safety Tables & Figures (ST&F): Data displays that reflect best practices gleaned from medical journals, subject matter experts, and data standard publications.
- FDA Medical Queries (FMQ): Standard groupings of adverse event terms designed by FDA to help identify potential safety issues during review of clinical trial adverse event data.
- Data Standards: Therapeutic-area technical specifications pertaining to sponsor submitted data sets that improve data consistency and reviewability.
Contact Us
E-mail: ONDBiomedicalinformatics@fda.hhs.gov
Resources
- FDA Study Data Standards Resources
- Public Workshop: Advancing Premarket Safety Analytics