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