Phase III Study Sample Clauses
A Phase III Study clause defines the requirements and parameters for conducting large-scale clinical trials to assess the efficacy and safety of a drug or treatment in a broad patient population. This clause typically outlines the study design, endpoints, regulatory standards, and reporting obligations that must be met before seeking marketing approval. By establishing clear expectations for Phase III trials, the clause ensures that both parties understand the scope and standards necessary for advancing a product toward commercialization, thereby reducing ambiguity and aligning development efforts.
Phase III Study. The term “
Phase III Study. The term “Phase III Study” shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Phase III Study. “Phase III Study” shall mean a well controlled clinical study commenced after the completion of a Phase IIB Study to confirm with statistical significance the efficacy and safety of a candidate drug in targeted patient populations, performed to obtain Regulatory Approval of a product.
Phase III Study. (-ies) shall mean the clinical study or studies as reasonably judged by BioMedicines to be adequate by the results of a meeting (or other communication) with the United States Food and Drug Administration (or other similar regulatory authority) to support the filing of a marketing application for the Licensed Product.