What are your thoughts on the new framework

Assignment Help Biology

Reference no: EM133517154

Assignment:

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.

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?

Reference no: EM133517154

Questions Cloud

Define the supportive-expressive continuum : Define the supportive-expressive continuum. Today's counseling practice has been shaped by several influential figures. name 10 of them.

Chernobyl impact environment ecosystems and soil : How did Chernobyl impact environment ecosystems and soil. Explain how biased perspectives influence what is known about both your historical and current events

Discuss elements of culture that influence buyer behavior : Elements of culture that influence buyer behaviour and give a personal example of how each has influenced a purchase decision you or your family made.

Do you think batterers can be reformed : Do you think batterers can be reformed? Are there certain types who can? Are there types who cannot?

What are your thoughts on the new framework : Will the framework provide value to internal reviewer communications and discussions related to premarket regulatory decisions?

Defined any ten key terms found in the back of the chapter : Defined any 10 Key Terms found in the back of the chapter. Choose any three sections of the chapter and summarizes them (100+ words per summary).

Common law enforcement tactic : Research and find why this is becoming a common law enforcement tactic. What are the critics of this practice using as their support to claim it is an illegal o

Documentation process start in investigation : Discuss why in the field of computer forensics it is important to document the findings? When should the documentation process start in an investigation?

How can healthcare administrators and executives positively : How can healthcare administrators and executives positively, in an administrative capacity, ensure the effective allocation of resources in their organization

User Account

All Pages