Which of the Following Is True Regarding FDA Approval of Drug

question 11

Multiple Choice

Which of the following is true regarding FDA approval of drug labels in relation to state law claims for failure to warn?

• A) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug nor does FDA approval of the label preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
• B) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, and federal law also preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.
• C) FDA approval of the label on a brand-name prescription drug preempts state failure-to-warn claims arising out of injuries caused by the drug, but federal law does not preempt state failure-to-warn claims related to approved generic drugs bearing the FDA-mandated label.
• D) FDA approval of the label on a brand-name prescription drug does not preempt state failure-to-warn claims arising out of injuries caused by the drug, but federal law preempts state failure-to-warn claims related to approved generic drugs as long as they bear the FDA-mandated label.

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Definitions:

Tax Deductible

Expenses or payments that can be subtracted from gross income to reduce the amount of income subject to taxation.

Term Bonds

Bonds that have a fixed maturity date on which the principal amount is due to be paid back to investors in full.

Serial Bonds

Bonds issued by a corporation or government that are scheduled for repayment at a series of future dates.

Installment Note

A loan that requires regular payments, or installments, of principal and interest over a set period of time.