Module 18 2021

08/02/2021

Biological Assessments

Stuart Freeman, Toxicology Consultant, Farino Consulting

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

1

Biological Assessment/Nonclinical Assessment

• Established device, established drug

Most likely

• Established device, new drug • New device, established drug • New device, new drug

Least likely

The Organisation for Professionals in Regulatory Affairs

2

1