Post-Approval Clinical Study definition

Post-Approval Clinical Study means (A) with respect to AVEO, any human clinical trial or registry either (i) required to be carried out by a Regulatory Authority in the AVEO Territory for the purpose of post-marketing surveillance of Licensed Product in the AVEO Territory or (ii) otherwise requested by Regulatory Authorities in the AVEO Territory after Regulatory Approval of Licensed Product in the AVEO Territory in an indication, designed to obtain additional information regarding Licensed Product’s risks, benefits and optimal use of that Licensed Product in such indication, and (B) with respect to Biogen Idec, any human clinical trial or registry either (i) required to be carried out by a Regulatory Authority in the Licensed Territory for the purpose of post-marketing surveillance of Licensed Product in the Licensed Territory or (ii) otherwise requested by Regulatory Authorities in the Licensed Territory after Regulatory Approval of Licensed Product in the Licensed Territory in an indication, designed to obtain additional information regarding Licensed Product’s risks, benefits and optimal use of that Licensed Product in such indication. For purposes of clarity, a clinical trial of Licensed Product in an indication for which such Licensed Product is not approved shall not be considered Post-Approval Clinical Study even if such trial occurs after such Licensed Product is approved in another indication.
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Post-Approval Clinical Study means any clinical study in humans with respect to any Licensed Product that is within or in support of, or intended to expand, the Product Labeling for any Licensed Product.
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Post-Approval Clinical Study means any clinical study involving the administration of and/or use of the Horizon System with a human subject conducted after Regulatory Approval of the Horizon System in order to support such Regulatory Approval or as otherwise required by a Regulatory Authority.
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Examples of Post-Approval Clinical Study in a sentence

  • OSB Lead PMA Post-Approval Study – ABSORB USA Post-Approval Clinical Study: The Office of Surveillance and Biometrics (OSB) will have the lead for studies initiated after device approval.

  • The ABSORB USA Post-Approval Clinical Study is a prospective, open- label, multi-center evaluation of the PMA-approved, commercially-distributed Absorb GT1 BVS.You must conduct a prospective, open-label, multi-center evaluation of the PMA-approved, commercially-distributed Absorb GT1 BVS consisting of at least 3,000 US patients that receive the device post-approval.

  • They have got that 2248 LEGISLATIVE ASSEMBLY OF MANITOBA 27, 1 998 ability.

  • At least [***] prior to the required delivery of the DexCom System for any Post-Approval Clinical Study, Insulet shall deliver to DexCom a forecast of the number of DexCom Systems it will require for such Post-Approval Clinical Study, along with the protocol for such Post-Approval Clinical Study (to the extent not already provided).

  • Table 1, Comparison of Hot and Cold License Guidance, shows the current experience requirement and the associated cold license experience method.

  • Neither Party shall conduct, and each Party shall cause its Affiliates and sublicensees not to conduct, any Non-Required Post-Approval Clinical Study except in accordance with the Development Plan.


More Definitions of Post-Approval Clinical Study

Post-Approval Clinical Study means any human clinical study with respect to a Lumacan Product for an indication that is not required to obtain or maintain MAA Approval for such Lumacan Product for such indication and is conducted within the scope of the Product Labeling for such Lumacan Product.
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Related to Post-Approval Clinical Study

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a 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 approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • 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.

  • 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 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.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.