Phase 3 Clinical Trial

Phase 3 Clinical Trial. Means a pivotal clinical trial that both (a) has a defined dose or a set of defined doses of a pharmaceutical product designed to ascertain efficacy and safety of such product, in a manner that is generally consistent with 21 C.F.R. § 312.21(c), as amended (or its successor regulation) and/or any analogous applicable law outside of the United States, as applicable, and (b) is necessary to enable Marketing Approval in the United States or any Major European Country.

Phase 3 Clinical Trial. A human clinical trial of a Product on a sufficient number of patients that is designed to (a) establish that a drug is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the drug in the dosage range to be prescribed; and (c) support Approval of such drug, as described in 21 C.F.R. § 312.12(c), or a similar clinical study prescribed by the regulatory authorities in a country other than the United States

Phase 3 Clinical Trial. Means a human clinical trial of a Product on a sufficient number of subjects that is designed to: (a) establish that such Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with such Product in the dosage range to be prescribed; and (c) support Regulatory Approval of such 5 Product, as described in 21 C.F.R. § 312.12(c), or a similar clinical study prescribed by the Regulatory Authorities in a country... other than the United States. A Phase 2/3 trial shall be considered to be both a Phase 2 Clinical Trial and a Phase 3 Clinical Trial. Any study publicly described as a pivotal study by BioMarin shall be considered a Phase 3 Clinical Trial View More

Phase 3 Clinical Trial. Shall mean a human clinical trial in any country, whether controlled or uncontrolled, that is performed after preliminary evidence suggesting effectiveness of the drug under evaluation has been obtained, and intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. In the United States, "Phase 3 Clinical Trial" means a human clinical trial that... satisfies the requirements of 21 C.F.R. § 312.21(c). View More

Phase 3 Clinical Trial. A Clinical Trial the design of which is intended to be sufficient for such Clinical Trial to be included as a pivotal efficacy and safety Clinical Trial in an NDA.

Phase 3 Clinical Trial. A Clinical Trial that is designed in a manner that is generally consistent with 21 CFR § 312.21(c)