Keyword: Investigator Initiated

Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE).

Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations

Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination