Phase IV Study definition

Phase IV Study means a human clinical trial of a product which is (a) conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval or (b) conducted voluntarily after Regulatory Approval of the product has been obtained from an appropriate Regulatory Authority for enhancing marketing or scientific knowledge of an approved Indication.

Phase IV Study means a post-marketing human clinical study for a Licensed Product with respect to any Indication with respect to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.

Phase IV Study means a clinical study or data collection effort for a Licensed Product that is initiated in one or more countries after the receipt of Regulatory Approval in such country(ies) and is principally intended to support the Commercialization of such Licensed Product in such country/countries and not to support or maintain the same or any additional Regulatory Approvals or otherwise obtain any labeling change. Phase IV Studies shall include, without limitation, clinical experience trials, but shall exclude post-approval studies that are required by a Regulatory Authority as a condition to receiving Regulatory Approval.

Examples of Phase IV Study in a sentence

• See, e.g., Charles Steenburg, The Food and Drug Administration’s Use of Postmarketing (Phase IV) Study Requirements: Exception to the Rule?, 61 FOOD & DRUG L.J. 295, 323 (2006) (Subpart H “extend[s] only to drugs and biological products that target[] ‘serious or life-threatening illnesses’ and offer[] a ‘meaningful’ benefit over existing treatments”).

• Protocol No. 704.351 Evaluation of Synergy between Natrecor and Furosemide on Renal and Neurohormone Responses in Chronic Heart Failure: A Phase IV Study, Scios Inc., 2003-2005 (multicenter, U.S., randomized cross-over trial).

• Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection-A Double Blind, Multi-Center, Randomized Phase IV Study.

• The JDMC shall not have any responsibilities in connection with: (i) any Phase IV Study; (ii) any commercialization or marketing activities in connection with the Product; or (iii) subject to Section 2.4(a)(vi), any manufacturing of commercial supplies of the Compound or the Product.

• A Randomized, Phase IV Study to Evaluate the Quality of Life of Subjects Infected with HIV-1 and who are Intolerant to Their Current Antiretroviral Therapy and Alter Therapy to Kaletra; Abbott Laboratories, Protocol: M00-267.

More Definitions of Phase IV Study

Phase IV Study means a post-marketing human clinical study: (a) for a Licensed Product with respect to any Indication as to which Regulatory Approval has been received or that is the subject of an investigator-initiated study program.

Phase IV Study means: (a) a post-approval clinical study for an Optioned Product with respect to any Indication for which Regulatory Approval has been received or that is required or agreed to be conducted as a condition of receiving Regulatory Approval in a country; as well as (b) any marketing study, epidemiological study, modeling and pharmacoeconomic study, investigator-initiated clinical trial or post-marketing surveillance study of an Optioned Product, in each case (for this clause (b)) that is not intended for use as a basis for obtaining Regulatory Approval (including expanded labeling) with respect to such Optioned Product.

Phase IV Study means any clinical study in human patients that is commenced after receipt of Regulatory Approval of a Cell Therapy Product in any country of the Territory, which study is conducted within the parameters of the Regulatory Approval, and shall include studies required or requested by the Regulatory Authority as a condition of, or in connection with, obtaining Regulatory Approval with respect to such Cell Therapy Product for a particular Cardiovascular Indication. Phase IV Studies also shall include studies conducted to gather additional information regarding such Cell Therapy Product, including, without limitation, potential risks, medical or pharmacoeconomic benefits, optimal use, dose, route and schedule of administration, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials.

Phase IV Study means a study required by a Regulatory Authority that is a Phase IV post-marketing and safety study, clinical experience study, and all other similar types of studies or investigations for a ThermoDox Product that is initiated in the Territory after receipt of a Marketing Authorization for such ThermoDox Product in the Territory and is principally intended to support the marketing and Commercialization of such ThermoDox Product, including, without limitation, clinical experience investigations and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization. For clarity, no Phase III Studies are included in this definition of Phase IV Studies. Phase IV Study also means the equivalent study in Japan.

Phase IV Study means, as applicable, a study or program, designed to: (a) obtain additional safety or efficacy data in support of the Product; or (b) determine effectiveness for additional labelled indications, in either case commenced after Governmental Approval of the Product in the subject country in the Territory.

Phase IV Study means clinical, preclinical, epidemiological modeling, and pharmacoeconomic studies that are designed to support marketing, publications, or future labeling changes within an approved indication.

Phase IV Study means a study initiated in a country after receipt of Regulatory Approval in such country within the approved product labeling.