Phase III definition

Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious 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; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

Examples of Phase III in a sentence

• With respect to cancer or other Life-Threatening Diseases or Conditions, a Qualifying Clinical Trial is a Phase I, Phase II, Phase III, or Phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other Life-Threatening Disease or Condition and that meets any of the following criteria in the bulleted list below.

• The tender must be placed in a properly sealed bigger envelope addressed to The Chief General Manager, NSIC-Technical Services Centre, Okhla Industrial Estate, Phase III, New Delhi and the said bigger envelope shall contain two sealed envelopes containing Technical & Commercial bids.

• Mr. Rhodes advised that this amendment involves a $63K modification due to decreasing a project for an HVAC unit at the Salvation Army that didn’t move forward, and adding the $63K to sidewalk improvements at Jane Frazier Village, Phase III.

• Exposure data from VIEW 1 and the extension study were pooled for the description of exposure in VIEW 1 (see Table SIII.1).311523/91689 (VIEW 2) was a randomized, controlled Phase III study of repeated IVT injections of 0.5 mg and 2 mg Eylea versus ranibizumab for 2 years in patients with wet AMD.VGFT-OD-0702 was a randomized, single-masked, long-term, safety, and tolerability study of IVT Eylea in Subjects with wet AMD.

• Superintendent's PresentationDr. Ficke updated the following topics:• Covid updates• Phase II feedback• Phase III implementationApproval of A motion by Mr. D’Andrea, seconded by Mr. Miller to grant approval of Minutes the March 11, 2021 regular and closed session minutes, and the March 18,2021 regular session minutes was carried unanimously.Report of Caitlin Pletcher, Board Solicitor, requested approval of the settlement The Solicitor agreement in the matter of Ralph Ross v.

More Definitions of Phase III

Phase III means Phase I (or Phase I/II), Phase II, and Phase III clinical trials, respectively, in each case as prescribed by the regulations of the applicable government agency or other regulatory entity.

Phase III means a human clinical trial of a Product or New Collaboration Compound on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Product or New Collaboration Compound, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise.

Phase III in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.

Phase III means that portion of the clinical development program which provides for the pivotal trials of a product in sufficient numbers of patients to establish the safety and efficacy of a product for the desired label claims and indications.

Phase III means Phase I, Phase II and Phase III clinical trials, respectively, in each case as prescribed by the U.S. Food and Drug Administration or a corresponding foreign entity.

Phase III means that portion of the clinical development program which provides for the continued trials of a Product on sufficient numbers of patients to establish the safety and efficacy of a Product for the desired claims and indications, as more specifically defined by the rules and regulations of the FDA and corresponding rules and regulations in other countries or jurisdictions.

Phase III means Phase III clinical trials as prescribed by applicable FDA regulations, regardless of whether such trials are conducted in the United States or elsewhere.