Regulatory Blog

The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled Early-Phase IND Protocol Recommendations for Solid Tumors, providing recommendations for sponsors and clinical investigators developing first-in-human (FIH) and other early-phase clinical trials involving investigational drugs and biological products for solid tumors. Developed by the FDA’s Oncology Center of Excellence (OCE), in collaboration with CDER and CBER, the guidance focuses on improving c