Phase 3 definition

Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

Phase 3 shall have the meaning set forth in Section 1.4.

Phase 3 means a controlled or uncontrolled human clinical trial of a compound or product that would satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalents.

Examples of Phase 3 in a sentence

• Final Version in one language o This should use final, professionally edited text and be based on the approved Phase 2 and Phase 3 deliverables.

• In addition to the second round of focus groups, CELs will identify opportunities to engage community members either by phone or at local gathering places to gather personalized feedback during Phase 2 Reflect and Phase 3 Refine in 2024.

• Where a term is defined both in this CfD (Phase 3) Agreement and in the Conditions, the definition in this CfD (Phase 3) Agreement shall apply instead of the definition in the Conditions.

• The two Phase 3 double- blind, randomised, placebo-controlled trials are identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16-week treatment period.

• One language • Deliverables: o Final version – one language incorporating all revisions made in Phase 3.

More Definitions of Phase 3

Phase 3 means a human clinical trial of a Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.

Phase 3 means a human clinical trial of a Molecule or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that such Molecule or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Molecule or Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.

Phase 3 means the third phase of human clinical trials of a drug required by the FDA or other equivalent regulatory authority to gain evidence of efficacy in the target population and obtain expanded evidence of safety for Product(s), as described in 21 C.F.R. Part 312, as it may be amended.

Phase 3 means that portion of the drug development and review process in which expanded clinical studies are conducted to gather the additional information to establish the effectiveness and safety that is needed to satisfy the requirements of a pivotal trial for obtaining regulatory approval to market an investigational new drug, as more specifically defined by the rules and regulations of the FDA or a similar regulatory requirement in any national jurisdiction.

Phase 3. “Phase 4”, “Phase 5”,”Phase 6”, “Phase A”, “Phase B” and “Phase C”. Except as expressly set forth in Sections 1.2.2, 1.3 and 1.4, Landlord shall deliver each Phase of the Premises to Tenant in its then “as-is” condition without any representations or warranties regarding condition.

Phase 3 means execution or construction phase.

Phase 3 means, in reference to a clinical study (or trial) of a Licensed Product, that as described in US federal regulation 21 C.F.R. § 312.21(c).