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:

Lithium

A chemical element often used in the treatment of bipolar disorder and other mood disorders.

Psychoanalytic Psychotherapy

A form of therapy that emphasizes the exploration of unconscious motivations and conflicts, based on Freudian theories.

Humanistic Therapies

A group of psychotherapies that emphasize personal growth and the concept of self-actualization.

Neuroleptics

A class of medications used to treat psychiatric disorders that affect a person's thinking, mood, or behavior, often by altering neurotransmitter levels in the brain.