Overview:
Why is it important to engage with the FDA?
To discuss your development plan to support NDA or BLA regulatory submission
To identify and mitigate potential issues early
To identify any critical issues and aspects of your program such as
Preclinical studies
Chemistry, Manufacturing and Controls (CMC) Considerations
Clinical Studies
Pediatric considerations
Statistics or regulatory considerations
Why is it important to engage with the FDA?
To discuss your development plan to support NDA or BLA regulatory submission
To identify and mitigate potential issues early
To identify any critical issues and aspects of your program such as
Preclinical studies
Chemistry, Manufacturing and Controls (CMC) Considerations
Clinical Studies
Pediatric considerations
Statistics or regulatory considerations
Who Should Attend
- Regulatory Affairs
- Marketing Department
- Compliance Specialists
- Clinical Project Leaders
