A pharmaceutical representative comes to the primary care office and states that his company is marketing a new drug that does not need approval by the Food and Drug Administration (FDA). What is the best response of the nurse?
nurse?
1. "Is this a drug in clinical trials? Those are the only drugs that don't have to have FDA approval."
2. "Is this an over-the-counter drug? Over-the-counter drugs do not need FDA approval."
3. "Your company must be involved in academic research if the drug doesn't need FDA approval."
4. "Any pharmaceutical company must have FDA approval before marketing a drug."
Correct Answer: 4
Rationale 1: Drugs in clinical trials must have FDA approval to start and continue clinical trials.
Rationale 2: Over-the-counter drugs must have FDA approval before being marketed.
Rationale 3: Drugs involved in academic research must have FDA approval.
Rationale 4: All drugs marketed by pharmaceutical companies must have FDA approval.
Global Rationale: All drugs marketed by pharmaceutical companies must have FDA approval. Drugs in clinical trials must have FDA approval to start and continue clinical trials. Over-the-counter drugs must have FDA approval before being marketed. Drugs involved in academic research must have FDA approval.
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