Ensuring the safety, effectiveness, and quality of human drugs is an increasingly complicated regulatory task, requiring FDA experts to consider a multitude of complex factors. Over the past several years, the FDA has developed an enhanced, structured approach to benefit-risk assessment in regulatory decision-making for human drug and biologic products. Review the attached document then answer the following questions.

https://www.fda.gov/media/84831/download

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?

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