Phase IV Studies means a study for a Collaboration Product that is initiated after receipt of a Marketing Authorization for a Collaboration Product and is principally intended to support the marketing and Commercialization of such Collaboration Product, including without limitation investigator initiated trials, clinical experience trials and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization.
Phase IV Studies means clinical studies designed to enhance sales for an approved indication, but shall not include Pharmacoeconomic Studies.
Phase IV Studies means a study or data collection effort for the Product that is initiated in the Territory after receipt of Regulatory Approval for the Licensed Product.
Examples of Phase IV Studies in a sentence
AM may conduct Phase III(b) Studies or Phase IV Studies at its own expense, and Cytogen shall have no rights to the benefits thereof.
More Definitions of Phase IV Studies
Phase IV Studies means clinical or other studies of any Agent which are undertaken following approval of the applicable NDA, and which are not required to be conducted as a condition of the FDA approval of the applicable NDA.
Phase IV Studies means any clinical study the results of which are intended to be used to support an expanded label claim for a Licensed Product in the Territory (even if such expanded label claims are marketed in the Territory under a different Marketing Authorization or trademark) such as new indications or formulations, or otherwise support marketing of a Licensed Product in the Territory.
Phase IV Studies means any post-Regulatory Approval after-market studies required to be performed by any Regulatory Authority in connection with the commercialization of the Licensed Product.
Phase IV Studies means those studies, including safety ---------------- surveillance studies, conducted under an Immunex IND which are agreed upon by Immunex and either the FDA or HPB, as applicable, as a condition of approval or maintenance of approval of an Immunex BLA or NDS for Enbrel, as the case may be, other than (a) Marketing Clinical Studies, (b) patient registries included within the definition of Marketing Expenses, and (c) those studies for a New Indication the cost of which are New Indication Expenses.
Phase IV Studies means clinical studies performed after obtaining Marketing Authorization for the purpose of supporting the marketing and Commercialization of the Product. For the avoidance of any doubt, “Phase IV Studies” does not include the RRS (as hereinafter defined).
Phase IV Studies means both post-marketing and pharmacoeconomic studies that are initiated by NBIX after Approval and are not requested, mandated or required by an Agency to support or maintain an Approval. Phase IV Studies does not include investigator initiated studies or Post-Approval Commitment Studies in the Territory.
Phase IV Studies means additional clinical studies for the Product commenced after the receipt of regulatory approval of the Regulatory Agency for the Product in all or part of the Territory, which studies are conducted within the parameters of the regulatory approval and other than those required or requested by the Regulatory Agency as a condition of or in connection with obtaining full regulatory approval. Phase IV Studies also include, but are not limited to, studies to gather additional information regarding the drug's potential risks, medical or pharmacoeconomic benefits, justifications and descriptions for other indications or comparative data to be included in United States compendial listings, and optimal use, dose, route, and schedule of administration, epidemiological studies, modeling and pharmacoeconomic studies, and investigator sponsored clinical trials, but specifically excludes PMS (as defined in Section 1.30 below).