Support for navigating the FDA’s Expanded Access Program to obtain investigational drugs, biologics or devices for patients with no other clinical options
Keyword: Food and Drug Administration
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
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics