Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study
Keyword: IND/IDE
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests to the FDA
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) applications to the FDA
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