611 Study definition

611 Study means the Phase III study as detailed within the current study protocol filed with the FDA under ****.
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Examples of 611 Study in a sentence

  • Spectrum shall perform the services necessary to continue to successfully conduct and complete the 611 Study and the 612 Study in compliance with the terms and conditions set forth in the 611 Study and 612 Study JDP using diligent efforts to meet the timetables set forth in the JDP.

  • Except for the 611 Study, 612 Study and BCG Refractory Study, nothing in this Agreement shall prevent Allergan from developing and performing any clinical trials with respect to the Licensed Product in the Field of Use in the Allergan Territory unilaterally and at its own expense.

  • Spectrum shall continue to be named as the sponsor of the 611 Study and 612 Study.

  • The portions of the JDP (including the work plan and budget) relating to the 611 Study and 612 Study are final and are hereinafter referred to as the “611 Study and 612 Study JDP”.

  • If the EMEA requests clinical trials for the Licensed Product beyond the 611 Study and 612 Study and the 1011 Study and 1012 Study, the Party who receives notice from the EMEA (or its equivalent) shall promptly provide such notice to the other Party.

Related to 611 Study

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • 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 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.