Question: Review the attached document then answer the following questions. Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making 1. What are your thoughts on the

Review the attached document then answer the following questions.

Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making

1. What are your thoughts on the new framework? Will this framework help the FDA to assess its risk-benefit decision making as it relates to disease areas where treatment options are less than optimal?

2. Will the framework provide value to internal reviewer communications and discussions related to premarket regulatory decisions?

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