Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]
Phase III Clinical Study means a study in human patients with a defined dose or a set of defined doses of a Product which study, if the defined end-points are met, is designed to ascertain or establish efficacy and safety of such Product in patients for the indication being studied for the purpose of preparing and submitting a Regulatory Approval Application to the competent Regulatory Authority in a country of the world.
Phase III Clinical Study means a pivotal study (whether or not denominated a “Phase III” clinical study under applicable regulations) in the Field in human patients with a defined dose or a set of defined doses of a Product designed to ascertain efficacy and safety of such Product for the purpose of enabling the preparation and submission of Drug Approval Applications to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. 312.21(c), as amended from time to time, or the corresponding foreign regulations.
Examples of Phase III Clinical Study in a sentence
Promptly following the Effective Date, Xxxxxx and GSK will establish a plan and timeline to transfer and assign ownership of all existing Marketing Approvals and other filings (if applicable) with Regulatory Authorities for the Compound and Product in the Territory to GSK, except as solely necessary for Amicus to conduct the 011 Phase III Clinical Study and/or 012 Phase III Clinical Study, as applicable.
More Definitions of Phase III Clinical Study
Phase III Clinical Study means, as to a particular Licensed Product, a clinical study in humans that is prospectively designed to assess the safety and effectiveness of such Licensed Product in a manner sufficient to file a Drug Approval Application for the Indication under investigation in the study. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase III Clinical Study” hereunder if such study has been designated by the sponsor as a Phase III clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).
Phase III Clinical Study means a human clinical study in any country conducted after Phase II Clinical Studies that is conducted to evaluate the comparative safety and efficacy of a drug or drug combination to the current standard of care, that would otherwise satisfy the requirements of 21 C.F.R. §312.21, or a similar clinical study in a country other than the United States. The data obtained is the principal data used by regulators for Regulatory Approval.
Phase III Clinical Study. Phase III Clinical Study means a human clinical study to confirm with statistical significance the efficacy and safety of Licensed Product performed to obtain Regulatory Approval for Licensed Product in any country, which shall be deemed commenced when the third patient in such study has received his or her initial dose of Licensed Product.
Phase III Clinical Study means (a) in connection with obtaining Marketing Authorization Approval in the United States, a Clinical Study that is conducted in human patients with a defined dose or set of defined doses of a Licensed Product, after successful completion of one or more Phase II Clinical Studies, designed to evaluate safety and therapeutic efficacy of a Licensed Product, to define warnings, precautions and adverse reactions associated with the Licensed Product in the dosage range to be prescribed, as more fully defined in 21 C.F.R. § 312.21(c), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.
Phase III Clinical Study means, as to a specific Licensed Product, (a) a human clinical study in any country, whether controlled or uncontrolled, that is performed to obtain Regulatory Approval of such Licensed Product after preliminary evidence suggesting its effectiveness under evaluation has been obtained, and intended to confirm with statistical significance the efficacy and safety of such Licensed Product, to evaluate its overall benefit-risk relationship and to provide an adequate basis for physician labeling, or (b) a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(c), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.
Phase III Clinical Study means a study of a Licensed Product in human patients with a defined dose or a set of defined doses of a Licensed Product designed to (a) ascertain efficacy and safety of such Licensed Product for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) support preparing and submitting applications for Regulatory Marketing Approval to the competent Regulatory Authorities in a country of the world, as and to the extent defined for the United States in 21 C.F.R.§ 312.21(c), or its successor regulation, or the equivalent regulation in any other country. Phase III Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase III” study.
Phase III Clinical Study means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).