Special Insurance Needs Of Biotech and Medical Device Firms

 

Where are you in the FDA Process?

 

CDER Process	CDRH Process
Initial Start-up Phase	Initial Start-up Phase
Pre-IND	Pre-510k or Pre-PMA
Phase I-III Clinical Studies	Clinical Studies in support of a PMA
NDA in preparation or NDA review in process	PMA in preparation or review in process