Phase III Clinical Trials definition

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.

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Phase III Clinical Trials means those trials on sufficient numbers of patients that are designed to establish that a drug is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the drug in the to be prescribed dosage range, and supporting Regulatory Approval of such drug.

Phase III Clinical Trials means human clinical trials conducted to establish efficacy of Product and meet requirements to file Applications for Marketing Authorization for Product with health regulatory authorities in the particular indication tested.

Examples of Phase III Clinical Trials in a sentence

Not later than the commencement of Phase III Clinical Trials for any Product, BTC and Auxilium will establish a Joint Commercialization Committee (the “JCC”) made up of two (2) representatives designated by each Party hereto to assist in coordinating interactions and resolving potential disagreements between BTC and Auxilium during the course of the Commercialization of Product.
Jazz may disband the Joint Steering Committee at any time if (i) all Work Plans are completed or terminated, (ii) Codiak has completed its obligations to conduct Phase I Clinical Trials, Phase I/II Clinical Trials, and Phase II Clinical Trials, (iii) Codiak has not exercised its Development and Commercialization Options and has no further right to exercise such an option and (iv) the Manufacturing of all Licensed Products has been transferred to Jazz or its Affiliates.
All Phase I Clinical Trials, Phase II Clinical Trials, and Combined Phase III Clinical Trials for the Licensed Product in the Field in the Territory shall be performed in compliance with and conformity to both FDA and EMEA requirements and to ICH Guidelines.
In the event that manufacturing batches for the U.S. are conducted prior to the commencement of Phase III Clinical Trials in Japan, Intercept shall afford DSP a reasonable opportunity to comment upon and make suggestions with respect to such manufacturing validation, which Intercept shall use good faith efforts to incorporate on a going-forward basis.
Subject to the following sentence, Pfizer shall have the exclusive right to Manufacture for the Phase III Clinical Trials and Commercialization of Licensed Products either itself or through one or more Affiliates or Third Parties selected by Pfizer, such Third Parties to be subject to Spark’s consent, such consent not to be unreasonably withheld or delayed.

More Definitions of Phase III Clinical Trials

Phase III Clinical Trials means a pivotal Clinical Trial with a defined dose or a set of defined doses of a therapeutic product designed to ascertain efficacy and safety of such product, in a manner that is generally consistent with 21 CFR § 312.21(c), as amended (or its successor regulation), for the purpose of enabling the preparation and submission of a BLA or a foreign equivalent thereof.

Phase III Clinical Trials means that portion of the Development Program that provides for human clinical studies in the Field that (a) are conducted in a number of patients that is intended to be sufficient to obtain a definitive evaluation of the therapeutic efficacy and safety of a Product in patients for a given Indication as required by 21 C.F.R. §312.21(c), and (b) are needed to evaluate the overall risk-benefit relationship of the Product and to provide adequate basis for obtaining requisite Regulatory Approvals.

Phase III Clinical Trials means investigational use of a Licensed Product for establishing its safety, efficacy, labeled indications, and risk–benefit profile in humans, under 21 C.F.R. Part 312 or comparable laws, rules, or regulations of another Regulatory Authority.

Phase III Clinical Trials means clinical trials designed to demonstrate safety and efficacy of a compound proposed to be used as a therapeutic pharmaceutical product in an expanded patient population at geographically dispersed study sites, meeting the requirements established by the FDA for Phase III clinical trials. A Phase III Clinical Trial is deemed to commence upon acceptance of a trial protocol with the FDA and concludes with the filing of an NDA with the FDA.

Phase III Clinical Trials means a clinical trial identified as a Phase III clinical trial in the Development Plan and conducted as a pivotal trial for purposes of filing a MAA for a Product that provides for the clinical study of such Product on a sufficient number of patients to confirm with statistical significance the efficacy, and confirm the safety of such Product, sufficient to support such MAA for such Product.

Phase III Clinical Trials has the meaning ascribed thereto in 21 C.F.R. Section 312.21(c), as amended from time to time.

Phase III Clinical Trials means clinical trials designed to demonstrate safety and efficacy of a compound proposed to be used as a prophylactic, therapeutic or diagnostic pharmaceutical product in an expanded patient population at geographically dispersed study sites, meeting the requirements established by the U.S. Food and Drug Administration for Phase III clinical trials.