Phase III Trial

Example Definitions of "Phase III Trial"
Phase III Trial. Means that portion of the clinical studies for the FDA submission and approval process which provides for trials of a product on sufficient numbers of patients to establish the safety and efficacy of such product to support regulatory approval in the proposed therapeutic indication as more fully defined in 21 C.F.R. Section 312.21(c).
Phase III Trial. A human clinical trial in any country that satisfies the requirements of 21 CFR 312.21(c), as amended from time to time, and the foreign equivalent thereof.
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