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1. In what year did the FDA first require patient package inserts in a drug product? (c.) 1970
2. In what year did drug manufacturers first have to show that a drug was safe before it could be marketed? (b.) 1938
3. What was the impetus for passage of the Biologics Control Act of 1902? (b.) deaths in St. Louis from tetanus contamination of diphtheria antitoxin
4. Medical devices are classified and regulated by the FDA according to: (c.) their complexity and degree of risk to the public
5. Microwave ovens are regulated by the FDA. How does the agency classify them? (b.) radiation-emitting product
6. The Cooper Committee was named for the: (a.) man who chaired the group
7. The FDA’s first device performance standard was developed for which product? (d.) impact-resistant lenses in eyeglasses and sunglasses
8. What was the name given to the volunteers who tested foods containing measured amounts of borax, salicylic acid, and other chemical preservatives in the early 1900s? (b) the Poison Squad
9. In dollars, what is the value of the domestic foods regulated by the FDA’s Center for Food Safety and Applied Nutrition? (d.) 240 billion dollars
10. In what year was the Nutrition Facts labeling first required on foods by law? (c.) 1992
11. The FDA’s Center for Drug Evaluation and Research serves as the consumer watchdog for roughly how many drugs on the U.S. market? (b.) 11,000
12. Which FDA scientists developed the German measles (rubella) vaccine? (a.) Parkman and Meyer
13. Which of the following is not regulated by the FDA’s Center for Biologics and Evaluation Research? (d.) whole organs for transplantation
14. What is the transplant of animal cells, tissues, or organs into a human called? (d.) xenotransplantation
15. How many drugs have been approved by the FDA to treat pet dogs, cats, and horses? (c.) more than 700
16. When Congress passed the Federal Food, Drug, and Cosmetic Act in 1938, what was the major way it strengthened the FDA’s powers? (a.) Manufacturers were required to show that their products were safe before they could sell them.
17. The FDA approved Vetsulin in 2004. What is it and what is it for? (c.) insulin for treating dogs with diabetes mellitus
18. The average daily allowance for an FDA inspector to stay one night in a hotel in early 1900 was: (a.) $4
19. How many FDA inspectors first started in 1907? (c.) 28
20. What was the principle way that drugs were regulated after the 1906 food and drug laws were passed? (c.) truthful labeling
21. For what magazine did Harvey W. Wiley work as director of the Bureau of Foods, Sanitation, and Health for 19 years? (b.) Good Housekeeping
18 to 21 points: Excellent! Go to the head of the class.
10 to 17 points: Not too bad. You can skip cleaning the chalkboard erasers today.
9 points and below: Oops! Stay after school and reread the appropriate chapters.