Phase IV definition

Phase IV means, as applicable, a study or program designed to obtain additional safety or efficacy data, detect new uses for a drug, or to determine effectiveness for labeled indications under conditions of widespread usage, which is commenced after Government Approval of the Product in the applicable country in the Territory or any such study or program required by the FDA or other applicable Governmental Authority.

Phase IV in reference to a clinical trial means a trial conducted for purposes of further characterizing and supporting the Product for marketing but not for purposes of seeking Regulatory Approval or otherwise fulfilling a requirement of a Regulatory Authority.

Phase IV means the phase of treatment for members who have been admitted for more than nine (9) months and who have successfully completed Phase III.

Examples of Phase IV in a sentence

• The treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial.

• The CONSULTANT shall retain all samples until acceptance of Phase IV plans.

• The treatment is being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trial for cancer.

• 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.

• With respect to cancer or other Life-Threatening Diseases or Conditions, a Qualifying Clinical Trial is 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 that meets any of the following criteria in the bulleted list below.

More Definitions of Phase IV

Phase IV means product support clinical trials of a Product with an approved label claim commenced after receipt of Regulatory Approval for such Product in the country where such trial is being conducted.

Phase IV means a human clinical trial conducted with respect to a Product: (a) after [… * …]; (b) within the [… * …]; and (c) intended as [… * …]. Phase IV studies may include, for example, [… * …], and the like. Except [… * …], Phase IV studies shall not include any human clinical trials: (i) [… * …]; and/or (ii) from which [… * …] for the purposes of: [… * …] or [… * …] provided that in the case of paragraph (ii), [… * …].

Phase IV means a clinical trial conducted for a Licensed Product under an IND in a particular country after the Licensed Product has received Marketing Approval and has been marketed and commercially sold in that country, which is conducted primarily to continue testing the Licensed Product to collect information about its safety and/or efficacy in broader or various populations, long-term safety and side effects associated with long-term use, and its use in additional indications other than that for which Marketing Approval was initially granted.

Phase IV means a human clinical trial of a product that is not included in the original NDA submission for such product for an indication, but is required to obtain or maintain the approval by a competent Regulatory Authority of the NDA for such product for such indication, including studies conducted to fulfil commitments made as a condition of NDA approval or any subsequent human clinical trials requested or required by a competent Regulatory Authority as a condition of maintaining such approval.

Phase IV shall have the following meanings:

Phase IV has the meaning specified in the Redevelopment Agreement.

Phase IV means, as applicable, a study or program designed to obtain additional safety or efficacy data, detect new uses for or abuses of a drug, or to determine effectiveness for labeled indications under conditions of widespread usage, which is commenced after a Marketing Authorization for Product is obtained; provided that for purposes of this Agreement certain Phase IV studies may commence prior to a Marketing Authorization for the Product being obtained.