Common use of Phase 3 Trial Clause in Contracts

Phase 3 Trial. The term “Phase 3 Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or its successor regulation).

Phase 3 Trial. The term “Phase 3 Trial” shall mean a human pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that would satisfy is needed to evaluate the requirements overall benefit-risk relationship of such product, to form the basis for the filing for approval of an NDA or BLA by a Phase 3 study Regulatory Authority and to provide an adequate basis for physician labeling, as defined described in 21 CFR C.F.R. § 312.21(c) (or its successor regulation)the corresponding regulation in jurisdictions other than the United States.