QUESTIONS AND ANSWERS REVISED
AND PASSED!!!.
1. Which area of drug R&D has seen the largest cost increases?
Answer: Clinical trials
2. On average, how long does it take for a new drug to be developed (i.e., from the
discovery of the initial compound to FDA approval)?
Answer: 10-15 years
3. Which of the following regulatory agencies is industry-based (i.e., run mainly by the
companies themselves)?
Answer: Pharmaceutical Research and Manufacturing of America (PhRMA)
4. Which of the following factors has simplified the pharmaceutical R&D process?
Answer: None of these
5. (T/F) The landmark FDA Modernization Act of 1997 was a major step forward in
enabling safe and effective new drugs and biologics to be made available sooner to patients.
Answer: True
6. According to your manual, which type of system is the best way to deliver healthcare?
Answer: A market-based system
7. How would increased pharmaceutical price controls affect the U.S. healthcare system?
Answer: Increased price controls would stifle innovation