Author Question: The student nurse is taking a pharmacology course and studying about the Food and Drug ... (Read 53 times)

storky111 · **on:** Jul 23, 2018

The student nurse is taking a pharmacology course and studying about the Food and Drug Administration (FDA). What has the student learned about how the FDA has decreased the amount of time involved in bringing a new drug to the market?

1. The Food and Drug Administration (FDA) is not as strict as it once was with regard to drug approval.
2. Since consumers have demanded more drugs, the Food and Drug Administration (FDA) has streamlined the review/approval process.
3. Drug manufacturers are required to pay yearly user fees, which allow the Food and Drug Administration (FDA) to hire more employees to increase its efficiency.
4. Drug manufacturers are required by the Food and Drug Administration (FDA) to test more drugs on an annual basis.

Question 2

The pharmaceutical representative comes to the physician's office and says his company's pharmaceutical laboratory is marketing a drug that does not need approval by the Food and Drug Administration (FDA). What is the best response by the nurse?

1. Any pharmaceutical laboratory in America must have approval from the Food and Drug Administration (FDA) before marketing a drug.
2. Is this an over-the-counter (OTC) drug? They do not need approval by the Food and Drug Administration (FDA).
3. Is your pharmaceutical laboratory private? Only public pharmaceutical laboratories need approval from the Food and Drug Administration (FDA).
4. Your pharmaceutical laboratory must be involved in academic research because they are exempt from approval by the Food and Drug Administration (FDA).

mistyjohnson · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

Correct Answer: 3
Rationale: In 1992, the Prescription Drug User Fee Act was passed. This required drug manufacturers to provide yearly product user fees so the Food and Drug Administration (FDA) could restructure, hire more employees, and operate more efficiently. The Food and Drug Administration (FDA) is just as strict now as it always was with regard to drug approval. The Food and Drug Administration (FDA) has not streamlined the review/approval process. The Food and Drug Administration (FDA) does not require drug manufacturers to test more drugs on an annual basis.

Answer to Question 2

Correct Answer: 1
Rationale: Any pharmaceutical laboratory, whether private, public, or academic, must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Private pharmaceutical laboratories must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories involved in academic research must obtain approval from the Food and Drug Administration (FDA) before marketing a drug. Pharmaceutical laboratories that manufacture over-the-counter (OTC) drugs must obtain approval from the Food and Drug Administration (FDA) before marketing these drugs.