NAPSR EXAM QUIZ 9, CHAPTER 9
QUESTIONS WITH COMPLETE
SOLUTIONS.
Which area of drug R&D has seen the largest cost increases? - ANS clinical trials
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)? - ANS 10-15 years
Which of the following regulatory agencies is industry-based (i.e., run mainly by the
companies themselves)? - ANS Pharmaceutical Research and Manufacturing of
America (PhRMA)
Which of the following factors has simplified the pharmaceutical R&D process? - ANS
none of these
(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. - ANS True
According to your manual, which type of system is the best way to deliver healthcare? -
ANS a market-based system
How would increased pharmaceutical price controls affect the U.S. healthcare system? -
ANS increased price controls would stifle innovation
Which of the following invests a greater percentage of sales in research than the
biotech sector? - ANS None of these
What was the intent of the Bayh-Dole Act and the Stevenson-Wydler Technology
Innovation Act? - ANS to hasten the commercialization of technologies that otherwise
might not be used
According to your manual, what did the G10 Medicines Group recently report about the
pharmaceutical industry in the European Union (EU)? - ANS There is poor collaboration
between publicity- and privately-funded research centers
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