Phase 2/3 Trial definition
Phase 2/3 Trial means a Phase 2 Trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((a) and (b)):
Phase 2/3 Trial means a Phase 2 Trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((a) and (b)):
(a) such trial is designed to (i) establish that the Product is safe and efficacious for its intended use, and (ii) define and determine warnings, precautions, and adverse reactions that are associated with the Product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such Product or a similar clinical study prescribed by the FDA; and
(b) such trial is or becomes a registration trial sufficient for filing an application for a Regulatory Approval for such Product in the U.S., as evidenced by (i) an agreement with or statement from the FDA on a Special Protocol Assessment or equivalent, or (ii) other guidance or minutes issued by the FDA, for such registration trial.
Phase 2/3 Trial means a Phase 2 Trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((a) and (b)):
(a) such trial is designed to (i) establish that the applicable pharmaceutical product is safe and efficacious for its intended use, and (ii) define and determine warnings, precautions, and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Marketing Approval for such Product or a similar clinical study prescribed by the FDA; and
(b) such trial is or becomes a registration trial sufficient for filing an application for a Marketing Approval the applicable pharmaceutical product in the U.S., as evidenced by (i) an agreement with or statement from the FDA on a Special Protocol Assessment or equivalent, or (ii) other guidance or minutes issued by the FDA, for such registration trial.
Examples of Phase 2/3 Trial in a sentence
Nothing herein shall modify Section 5.1(b) with respect to any Clinical Trial other than the IC Phase 2/3 Trial and the rIFI Trial as set forth herein.
The IC Phase 2/3 Trial is an adaptive design trial that is intended to commence as a Phase II Clinical Trial that can convert to a Phase III Clinical Trial.
More Definitions of Phase 2/3 Trial
Phase 2/3 Trial means a human clinical trial in any country that is designed to generate additional data related to dosing and the effect of the relevant pharmaceutical product on the target patient population sufficient to serve as one of the pivotal trials to enable filing of an NDA.