Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Biological Assessments

Chris Carr, Head of Regulatory Affairs Cell and Gene Therapy Catapult

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in 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