Which of the following is/are true related to the development and approval of generic drugs (select all that apply):

Question

Answer

There are typically no clinical trial costs that need to be recovered through product sales

Answer

Instead of clinical trials, generic companies typically have to conduct bioequivalency studies to demonstrate that the product is equivalent to the innovator company's product

Answer

It typically takes generic companies 3 years from the beginning of product development through product approval (instead of 15-17 years for an innovator company)

Answer

There are no discovery costs that need to be recovered through product sales

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The generic company files an "abbreviated" new drug application

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Which of the following is/are true related to the development and approval of ge...

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