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Chapter 1 online practice quiz

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
Created by: sloera19