Your company, DrugsRUs, has developed a genericangiotensin-converting-enzyme inhibitor, Vasotec, as apharmaceutical drug used primarily for the treatment ofhypertension and congestive heart failure. You are leading theregulatory strategy team and have been asked to describe the pathto approval comparing introduction in the US versus Brasil.
Please discuss the following:
(1) Which agency or agencies will be responsible forapproving/reviewing your Vastec drug: (a) before commercialintroduction, and (b) after approval for commercialization/salewithin the US., and
(2) Compare known issues your company will need to consider tomarket your generic drug is Brasil.
