Phase III Study means 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 means a study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient (alone or together with one or more other such studies) to file an application for Regulatory Approval for such product, as further defined in 21 C.F.R. § 312.21(c) (or the equivalent thereof outside the United States).
Phase III Study means a large scale human clinical trial in any country that would satisfy the requirements of 21 C.F.R. 312.21(c) (as amended) (whether or not such trial is for the FDA), but which is not a Phase IV Study.
More Definitions of Phase III Study
Phase III Study means a pivotal clinical study in human patients with a defined dose or set of doses of a Clinical Development Candidate that is designed to ascertain the safety and efficacy of (or to otherwise satisfy the requirements of 21 C.F.R. § 312.21(c) or its foreign equivalent with respect to) such Clinical Development Candidate for a particular Cardiovascular Indication, which Phase III Study is conducted for the purpose of enabling the preparation and submission of applications for Regulatory Approval to the competent regulatory authorities in a country of the Territory.
Phase III Study means a controlled Clinical Study in human subjects of the efficacy and safety of a Licensed Product, which is prospectively designed to demonstrate statistically whether such Licensed Product is effective and safe for use in a particular indication in a manner sufficient to file an application to obtain Regulatory Approval to market such Licensed Product as further defined in 21 C.F.R. § 312.21(c) (or the non-United States equivalent thereof).
Phase III Study means, in respect of a Sublicensed Product, (a) that portion of the FDA submission and approval process in which expanded clinical studies are conducted to gather the additional information about effectiveness and safety that is need to evaluate the overall benefit-risk relationship of a product as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(c) or any future revisions or substitutes thereof; or (b) a similar clinical study in any natural jurisdiction other than the United States.
Phase III Study means a Phase III clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.
Phase III Study means a clinical trial of a Product generally consistent with 21 CFR §312.21(c) or equivalent trial outside of the United States, which, for clarity, includes any open label extension.
Phase III Study means, as to a particular product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such product for such indication, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use in such indication in a manner sufficient to file a Drug Approval Application to obtain Regulatory Approval to market and sell that product for the indication under investigation in such study.
Phase III Study has the meaning set forth in the Master Agreement.