Use in First In Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Use in First In Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. These are trial designs that employ multiple, concurrently accruing subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product.