Phase III Clinical Trial definition

Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Phase III Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c), as may be amended, or the foreign equivalent thereof.

Examples of Phase III Clinical Trial in a sentence

• For clarity, notwithstanding the negotiation of the Commercial Supply Agreement prior to initiation of the Phase III Clinical Trial for the Covered Product, any Clearside Devices Manufactured and supplied for use in the Phase III Clinical Trial or any Phase IV Clinical Trial will be Manufactured and supplied pursuant to Section 4.2 (Preclinical and Clinical Manufacture and Supply of Clearside Devices), not the Commercial Supply Agreement.

• During the Term and until the initiation of a Phase III Clinical Trial for the Covered Product, the Parties shall hold meetings at least [***] per Calendar Year (or such other frequency as mutually agreed by the Parties) for BioCryst to present and share any updates and progress regarding the Exploitation of the Covered Product during such immediately preceding Calendar Year (or such other period as mutually agreed by the Parties).

• A more detailed analysis plan, including a valid subgroup analysis, should be included for a Phase III Clinical Trial.

• Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.

More Definitions of Phase III Clinical Trial

Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal study, whether or not such study is a traditional Phase III study.

Phase III Clinical Trial means a clinical trial of a Product generally consistent with 21 C.F.R. § 312.21(c) (or the non-United States equivalent thereof).

Phase III Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c).

Phase III Clinical Trial means a human clinical trial of a compound or product for an indication on a sufficient number of subjects that is designed to establish that the compound or product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the compound or product in the dosage range to be prescribed, and to support Regulatory Approval of the compound or product for such indication or label expansion of the compound or product. For clarity, the term “Phase III Clinical Trials” includes early access and compassionate use programs.

Phase III Clinical Trial means the third phase of a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Licensed Product as a basis for an NDA or would otherwise satisfy requirements of 21 CFR 312.21(c) in the United States, or its European equivalent. ***Confidential Treatment Requested

Phase III Clinical Trial means one or more clinical trials on sufficient numbers of patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Regulatory Approval of such drug.

Phase III Clinical Trial means 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 for Marketing Authorization, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(c) or its foreign equivalents.