505(b)(2) New Drug Application

**Semantic type:** Intellectual Product

**Definition:** A 505(b)(2) drug development program must demonstrate safety and efficacy to the same standards as a 505(b)(1) program. However, existing data from studies not conducted by or for the sponsor, and for which the sponsor does not have right of reference, may be used to meet some or all of the safety and efficacy requirements. This usually means a 505(b)(2) drug product can be developed with less risk, in less time, and at lower cost.

**Synonyms:** - 505(b)(2) NDA