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MOD 3
Chapter 1 online practice quiz
| Question | Answer |
|---|---|
| On the schedule for controlled substances, to which category does heroin belong? | C-I |
| Which law required all new drugs to be proved safe before being marketed? | Food, Drug, and Cosmetic Act of 1938 |
| In naming a new drug, a drug manufacturer tries to select a name that | can be identified by physicians and pharmacists in other countries, indicates the active component in a single word |
| Which drug is the most expensive? | Epoetin alfa |
| The drug name omeprazole is a | generic name |
| Which of the following helps to ensure that drugs that pose serious safety threats are promptly removed from the market | Office of compliance, MedWatch, Phase IV clinical trials |
| FDA approval of a new drug means that the drug | presents benefits that outweigh its risks |
| When a company's patent on a proprietary drug expires, other companies | are free to produce this drug as a generic drug, must obtain FDA approval to market their version of the drug |
| What is the role of the Food and Drug Administration (FDA) in bringing a new drug to the marketplace | to grant approval for experimental drug testing, to review the results of drug testing |
| What was the purpose of the prescription drug user fee act of 1992? | to shorten the review process of new drugs |
| In which phase of clinical trials are short-term, placebo-to-drug comparisons begun? | Phase II |
| Under patent protection, the drug's sponsor | owns the drug's generic and brand names, has the sole right to manufacture the drug, can seek to recoup its investment in the drug's development |
| What percent of drugs that enter clinical trials are ultimately approved for marketing? | 20 % |
| Which publication identifies generic drugs that are not therapeutically equivalent to their innovator drugs? | orange book |
| What is the role of the FDA in the area of food products? | to ensure that food products meet certain labeling standards |
| Drugs designated as controlled substances | have high potential for abuse |
| The Food and Drug Administration regulates | veterinary drugs, medical devices, legend drugs |
| The prescribers's _______ registry number must be associated with the prescription for a controlled substance. | DEA |
| A loophole in federal regulations allows drug companies | to reuse OTC brand names for products with different ingredients |
| Which FDA pregnancy category indicates that a drug is safe to use by pregnant patients? | A |
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sloera19
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