SECTION 1
DRUG X—APPROVAL
11/10/2005

1. Public Health Question

This section of the BRAMP document specifies the public health problem or question that prompted a review of the benefits and risks associated with a drug. At the time of approval for marketing, the public health question is whether the benefits of Drug X outweigh its risks and, therefore, whether the drug should be approved for marketing.

This section also should include a discussion of the context in which the public health question is asked. That is, it includes characteristics of the condition that the drug is approved to treat for, patients’ perceptions and concerns, practical considerations, availability of other treatments, and any other issues that should be considered in addressing the public health question.

2. Summary of the Benefit and Risk Assessment

This section should include a description of the process used to assess the benefits and risks, including how stakeholder input was sought and incorporated. It should also include, in the sections below for benefit and for risk assessments, a summary of the available evidence used, the quality and uncertainty of the different studies, and the judgments made about the different studies, including how the studies were factored into decisions. The description of the evidence should include a characterization of the overall consistency and uncertainty of that evidence. All assumptions used in estimating benefits and risks should also be described.

a. Benefit Assessment

This section should include a description of the evidence used in the assessment of the benefits of the drug, including the quality, consistency, and relevance of the data.

b. Risk Assessment

This section should include a description of the evidence used in the assessment of the risks posed by the drug, including the quality, consistency, and relevance of the data.

c. Overall Benefit–Risk Profile

This section should include a description of the evidence used in the assessment of the benefit–risk profile of the drug, including the quality, consistency, and



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