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The Brief Summary is a quarterly bulletin intended for all Office of Prescription Drug Promotion (OPDP) stakeholders. The Brief Summary provides news and updates related to OPDP.
As used in this guidance, the term efficacy refers to the findings in an adequate and well-controlled clinical. 2. trial or the intent of conducting such a trial and the term effectiveness refers to the regulatory determination that is made on the basis of clinical efficacy and other data.
Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairly and reasonably be concluded by experts qualified by
It summarizes data relevant to safety in the intended population, integrating the results of individual clinical study reports as well as other reports such as the integrated analyses of safety performed in the ISS. The SCE provides a comprehensive overview of the efficacy of the drug.
The ISE is a comprehensive integrated analysis of the effectiveness of a study drug. The purpose of the ISE is to describe the available information regarding effectiveness, delineate strengths and weaknesses, and highlight important missing information.
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The SSED is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.

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