Regulatory Resources


Template Documents

These template documents are meant to serve as a guide. We recommend that you reference the regulations and applicable guidance documents as you prepare your submissions. Please contact our team at with any questions or suggestions. 

Sponsor-Investigator IND Templates


INTERACT Meeting Templates (CBER)

​Pre-IND and End-of-Phase Meeting Templates

Initial IND Submission Templates

Investigative Brochure Template

Annual Report Templates

Transfer of Ownership Templates

Other Documents


Sponsor-Investigator IDE Templates


Pre-Submission Templates

Study Risk Determination Templates

Initial IDE Templates

Progress Report Template


Sponsor-Investigator ITP Templates


Investigational Tobacco Product Template


Orphan Drug Designation Templates


Initial Request

Annual Progress Report


Financial Disclosure Template


Protocol Templates