Phase 3 Study

Phase 3 Study. A controlled study in humans of the efficacy and safety of a product, which is prospectively-designed to demonstrate statistically whether such product is effective and safe for use in a particular Indication in a manner sufficient to file an NDA to obtain Regulatory Approval to market the product, as further defined in 21 C.F.R. § 312.21(c) (or the non-United States equivalent thereof)