Pivotal Clinical Trial means a human clinical trial of a Licensed Product that (a) would satisfy the requirements of 21 C.F.R. 312.21(c) or corresponding foreign regulations; or (b) that is intended to provide sufficient efficacy data to support the Filing of a BLA for such Licensed Product in such country. A Pivotal Clinical Trial includes a Phase 2 Clinical Trial or Phase 3 Clinical Trial that satisfies the foregoing definition.
Pivotal Clinical Trial means a human clinical trial of a product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ((a) and (b)):
Pivotal Clinical Trial means, with respect to a Product, a Clinical Trial in humans performed to gain evidence with statistical significance of the efficacy of such Product in a target population, and to obtain expanded evidence of safety for such Product that is needed to evaluate the overall benefit-risk relationship of such Product, to form the basis for filing an Approval Application and obtaining Marketing Approval from a Regulatory Authority for such Product. [***].
Examples of Pivotal Clinical Trial in a sentence
Reynolds, M.A. and Aichelmann-Reidy, M.E. The Era of Biologics and Reparative Medicine: A Pivotal Clinical Trial of Platelet-Derived Growth Factor for Periodontal Regeneration.
The TACT Pivotal Clinical Trial is a prospective, open-label, single-arm pivotal clinical study, of 115 treatment-naïve localized prostate cancer patients across 13 research sites in the United States, Canada and Europe, which enrolled patients between August 2016 and February 2018.
The “DeNovo 510K Regulatory Schedule” contained in the Agreement forecasted that enrollment of the 210 patients for the CLI Pivotal Clinical Trial would be complete by March 31, 2013.
The Local Coordinating Board (LCB) shall establish a process and procedure to provide regular opportunities for issues to be brought before such committee and to address them in a timely manner in accordance with the Commission’s Local Grievance Guidelines.
The Class Period begins on September 25, 2017, when Acer issued a press release announcing “Positive Results From Pivotal Clinical Trial of EDSIVO” for the treatment of vEDS (the “September 2017 Press Release”).
More Definitions of Pivotal Clinical Trial
Pivotal Clinical Trial means a human clinical trial (whether denominated “Phase II”, “Phase III”, or otherwise) conducted to establish efficacy of Licensed Product and to meet the requirements to file a New Drug Application for Licensed Product with health regulatory authorities in the particular indication tested.
Pivotal Clinical Trial means a human clinical trial of a product on a sufficient number of subjects that satisfies both of the following ((a) and (b)):
Pivotal Clinical Trial means a pivotal study in human patients with a defined dose or a set of defined doses of the Product designed or intended to ascertain efficacy and safety of the Product for the purpose of enabling the preparation and forming the primary basis for submission of a BLA for the Product to the competent Regulatory Authority in a country of the Territory, which may be a Phase 3 study as further defined in 21 C.F.R. 312.21(c), as amended from time to time, or a Phase 2 study as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or in each case defined in the corresponding regulations in any jurisdiction or country other than the United States, or any amended or successor regulations.
Pivotal Clinical Trial means a randomized, controlled clinical trial of a Product designed to demonstrate statistically significant clinical efficacy and safety in human patients (in conjunction with performance of a therapeutic procedure) pursuant to a clinical study agreed with the FDA, which trial the FDA accepts as a pivotal clinical trial necessary for Regulatory Approval of such Product. An outline of the structure of the initial Pivotal Clinical Trial is attached as Schedule 1.35.
Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.
Pivotal Clinical Trial means (i) a human clinical trial of a Product that is intended to be a pivotal trial for obtaining Regulatory Approval (e.g., in the United States such clinical trial is conducted after the end of phase 2 meeting with the FDA) and to otherwise establish safety and efficacy in patients with the disease or condition being studied and to provide an adequate basis for physician labeling, for purposes of filing a MAA for Product, and that would satisfy the requirements under 21 C.F.R. 312.21(c) or foreign equivalents thereof, or (ii) any other clinical trial that is intended 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 trial is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for such product in the United States 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 clinical trial.
Pivotal Clinical Trial means a pivotal human clinical trial of a Product (whether or not denominated a “Phase 3” clinical trial under applicable regulations) with a defined dose or a set of defined doses of such Product designed to ascertain efficacy and safety of such Product for the purpose of enabling, without the performance of additional human clinical trials, the preparation and submission of an MAA to the applicable Regulatory Authorities in a country of the Licensed Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.