Once a Drug or Device Has Been Approved for Use

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