Treatment Investigational New Drug Study

**Semantic type:** Research Activity

**Definition:** Expanded access to an investigational medical product (drug, biologic, or medical device) for treatment use by a large (widespread) population, submitted under a new Investigational New Drug (IND) application. (FDA: Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance for Industry, June 2016)

**Synonyms:** - Treatment IND Study