Examples of Post-Approval Study in a sentence
Subject to the terms and conditions of this Agreement, UCB (or its designee) shall supply, in a timely manner in quantities and timing as agreed by the JDT to satisfy the Development activities set forth in the Development Plan in the manner set forth in the Development Responsibility Matrix, with required quantities of the Product in final packaged form, and Comparator Drugs and Placebo, to be used in a Phase 3 Study, and any Post-Approval Study in the Development Indication.
Two (2) copies of each report, identified as an "ODE Lead PMA Post-Approval Study Report" or "OSB Lead PMA Post-Approval Study Report" in accordance with how the study is identified below and bearing the applicable PMA reference number, should be submitted to the address below.
Dermira shall provide to the JDT a draft of the form of Clinical Site Agreement that Dermira proposes to use in connection with the Development of the Product in the Development Indication in the Development Territory through the conduct of a Phase 3 Study, or a Post-Approval Study, which draft form shall be approved by the JDC as a Development Matter prior to the date on which Dermira first expects to use such form.
We don’t have one so select No (probably the default) and click Next >.
Dermira shall diligently, in good scientific manner and in accordance with prevailing industry practices concerning the conduct of Clinical Studies, GCP, ICH Guidelines and Applicable Law, attempt to identify, or cause to be identified, and to resolve expeditiously, inconsistencies and deficiencies in Product Data from any Phase 3 Study, or any Post-Approval Study in the Development Indication, conducted by or on behalf of Dermira.