Which of the following statements about the US FDA are true? Select ALL that apply.Group of answer choicesThe FDA is responsible for ensuring that medications are both safe and effective before approvedThe FDA has legal authority to issue an Emergency Use Authorization for unapproved products to be used in an emergency situation when certain criteria are met and there are no adequate, approved and available alternativesThe only source of funding to the FDA is from the federal budgetOn average, fewer than 10% of investigational drugs ever make it past the valley of death during the drug development pipeline.
Question
Which of the following statements about the US FDA are true? Select ALL that apply.Group of answer choicesThe FDA is responsible for ensuring that medications are both safe and effective before approvedThe FDA has legal authority to issue an Emergency Use Authorization for unapproved products to be used in an emergency situation when certain criteria are met and there are no adequate, approved and available alternativesThe only source of funding to the FDA is from the federal budgetOn average, fewer than 10% of investigational drugs ever make it past the valley of death during the drug development pipeline.
Solution
The first two statements about the US FDA are true.
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The FDA is indeed responsible for ensuring that medications are both safe and effective before they are approved. They do this through a rigorous process of testing and review.
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The FDA does have the legal authority to issue an Emergency Use Authorization for unapproved products to be used in an emergency situation when certain criteria are met and there are no adequate, approved, and available alternatives. This has been particularly relevant during the COVID-19 pandemic.
The third statement is not entirely true. While the FDA does receive funding from the federal budget, it also collects fees from the industries it regulates, such as pharmaceutical and medical device companies.
The fourth statement is generally true. Drug development is a risky process and many investigational drugs do not make it to market. However, the exact percentage can vary and is not always less than 10%.
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