Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study 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 clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.
Pivotal Study means a controlled pivotal clinical study of a product that is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to obtain Regulatory Approval to market such product in a Major Market Country.
Pivotal Study means a human clinical trial 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 Approval of such Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar Clinical Trial prescribed by the Regulatory Authorities in a foreign country.
Examples of Pivotal Study in a sentence
For the purposes of clinical evaluation, Gore considered combined outcomes between the U.S. and Brazil protocols to assess the TAMBE Device performance and to inform the TAMBE Pivotal Study.
Pivotal Study of a Next- Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease.
The TAMBE Pivotal Study results confirm that frequently the risks associated with endovascular repair using the TAMBE Device can be successfully identified through perioperative monitoring and routine follow up and can often be successfully mitigated with additional minimally invasive procedures.
Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator’s clinical judgment Screening Assessments Subjects who appear to meet the eligibility criteria and have signed the informed consent will continue to the screening visit which will be performed either over the phone (for subjects currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270) or at the clinical study site.
This study is a non-randomized, multicenter, prospective study that consists of continued follow-up of all available subjects from the IDE Pivotal Study and the continued access subjects.
More Definitions of Pivotal Study
Pivotal Study means a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specific intended use, in a statistically justified number of subjects.
Pivotal Study means a controlled pivotal clinical study of a Licensed Product that is prospectively designed to demonstrate statistically whether such Licensed Product is effective and safe for use in a particular indication in a manner sufficient to obtain Marketing Approval to market such product in the United States, China, Japan or Germany (via the European Union (including the European Medicines Authority) or otherwise).
Pivotal Study means Phase 3 Study or other clinical study of a drug candidate in human patients with the disease being studied, in each case, the principal purpose of which is to achieve a determination of efficacy and safety and is designed and intended to provide the basis for obtaining Regulatory Approval to market the applicable product for patients with the indication being studied or where a Clinical Study subsequently is deemed to achieve efficacy and safety for the applicable product and indication for the purpose of obtaining Regulatory Approval.
Pivotal Study means a clinical trial that, if the defined end-points are met, is designed (and agreed to in advance by a Regulatory Authority(ies) having jurisdiction in the country(ies) in which the trial is to be conducted, based upon existing data in the same patient population as of the start of such clinical trial) to definitively establish that an Antibody Product drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the Antibody Product in the dosage range to be prescribed, and provide pivotal data supporting Regulatory Approval of such Antibody Product and that satisfies the requirements of 21 CFR 321.21(c) (or its successor regulation), or its equivalent in any other jurisdiction.
Pivotal Study means the clinical trial initiated for the Product by the Company, entitled “RECONNECT (A Randomized, Double-Blind, Placebo-Controlled, Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children, Adolescents, and Young Adults with Fragile X Syndrome)” under the protocol number ZYN2-CL-033.04.
Pivotal Study means a clinical trial conducted outside North America that is required to be filed with the FDA in order to obtain marketing approval in the United States and that is designated as a "pivotal study" for such purposes by the Development Committee. RPRP Development Costs ("Costs") shall be adjusted to then-current dollars using the change in the Consumer Price Index, U.S. Cities Average for All Urban Consumers, as published by the U.S. Department of Labor, Bureau of Labor Statistics from the date the Costs are incurred until the date such costs are recouped.
Pivotal Study means (i) a Phase III Study intended to provide evidence for the target product claims in connection with, and to support a submission for, Regulatory Approval to market a product or (ii) that portion of a Clinical Trial (including a Phase II Study) that is not a Phase III Study but that is intended to support or which has the potential to form the basis for Regulatory Approval of a product.