each for one page
no need for the reference

1. There are conflicting opinions regarding the historical effectiveness of FDA’s regulatory pathway for manufacturers to obtain marketing approval for new biosimilar therapeutic products.  In 2-3 paragraphs please explain your own opinion as to why FDA’s marketing approval process for new biosimilar products is or is not effective?  As part of your answer please include an assessment of regulatory and other types of variables that both proponents, as well as opponents, of the process have used to describe their own opinion.  Should FDA’s biosimilar therapeutic marketing evaluation process remain the same, or do you believe it should be modified in some way?

2.Do you believe it is possible for FDA to accelerate its current new pharmaceutical and/or biologic approval processes without compromising patient safety?  If so, how can this be done?  If not, why not?