A course introducing the regulatory responsibilities of sponsors and investigators in drug and device studies
Keyword: IDE
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics
FDA regulations for conducting clinical trials involving non-significant risk devices
Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination
Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study
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
Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE)