The nurse is participating in the New Drug Review step for a new ...

[ETearle]

The nurse is participating in the New Drug Review step for a new therapeutic agent. Which activities will the nurse most likely perform during this phase of the drug approval process?
 
  1. Attend meetings to finalize the brand name for the drug.
  2. Check on the results of animal testing.
  3. Survey for harmful effects in a larger population.
  4. Evaluate the results of the drug on cultured cells.
  5. Provide the medication to large groups of people with a particular disease.

Question 2

While reading a medication package inserts the nurse notes the information contained within the black box. What is the significance of this information to the nurse?
 
  1. The drug can cause special problems.
  2. It identifies extreme adverse drug reactions.
  3. It differentiates a prescribed medication from an over-the-counter medication.
  4. It highlights the cost of the medication.
  5. It signifies the medication is generic.

[jaygar71]

Answer to Question 1

Correct Answer: 1,2
Rationale: During the NDA or the third stage of the drug approval process the drug's brand name is finalized.

Answer to Question 2

Correct Answer: 1,2
Rationale: The FDA created boxed warnings in order to regulate drugs with special problems.

[ETearle]

Thanks

[jaygar71]

Welcome