Additional Resources on COVID-19 FDA Guidance
- Changes to study visits and assessments – focus on subject safety
- Choosing the right path with FDA (webinar)
- Conduct of ongoing clinical trials (guidance)
- Development of COVID-19 therapies – FDA pathways
- Drug shortages
- Protocol amendments and clinical study reports (guidance)
- Site management and monitoring
- Trial integrity – statistical rules of thumb
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency