Once a Drug or Device Has Been Approved for Use

question 8

Multiple Choice

Once a drug or device has been approved for use in the United States, the _____.

• A) DEA may withdraw approval if a safety concern exists
• B) only action that can be taken is requirement of additional warnings to be added to the labeling and recommendation for voluntary withdrawal by the manufacturer
• C) FDA may reconsider its approval and withdraw it from the market to protect the public safety
• D) DEA may demand withdrawal from the market

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Definitions:

Official Poverty Rate

A statistical measure determined by the government that defines the percentage of the population whose income falls below the threshold considered necessary to meet basic living needs.

Money Income

The total amount of monetary earnings received by an individual or household, including wages, salaries, and other sources of income.

Noncash Benefits

Benefits provided to individuals or groups that are not in the form of cash, such as food stamps, health insurance, or housing assistance.

Incidence Of Poverty

Refers to the proportion of the population living below the poverty line, indicating the level of poverty within a community or country.