Your company, DrugsRUs, has developed a generic
angiotensin-converting-enzyme inhibitor, Vasotec, as a
pharmaceutical drug used primarily for the treatment of
hypertension and congestive heart failure. You are leading the
regulatory strategy team and have been asked to describe the path
to approval comparing introduction in the US versus Brasil.
Please discuss the following:
(1) Which agency or agencies will be responsible for
approving/reviewing your Vastec drug: (a) before commercial
introduction, and (b) after approval for commercialization/sale
within the US., and...