Is it weighted too heavily in favor of drug sponsors

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Do you think the FDA does an adequate job of balancing the market protections ( the four main statutory marketing protections listed on page 190) and need for innovation with patient interests, such as safety and cost considerations? Select one of the statutory market exceptions and discuss whether you agree or disagree with the protection as a balanced approach. Is it weighted too heavily in favor of drug sponsors? Does the need for this protected class of product outweigh the need for a competitor to enter the market? Why or why not?

Reference no: EM133669526

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