Your company, DrugsRUs, has developed a generic angiotensin-converting-enzyme inhibitor, Vasotec, as a pharmaceutical drug used primarily for...

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Biology

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.

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1a In US The food and drug administration FDA regulates which drug will get the approval and which not It has six center one of it is Center for Drug Evaluation and Research CDER To market a new See Answer

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