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11)This legislation required drug safety testing. A)1962 Amendment to the Food, Drug, and Cosmetic Act B)Food, Drug, and Cosmetic Act of 1938 C)Food and Drug Act of 1906 D)1959 Kefauver Senate hearings 12)About 20 to 100 people participate in this new drug trial phase. A)Phase IV B)Phase II C)Phase I D)Phase III 13)Several hundred people participate in this drug-testing phase. A)Phase II B)Phase I C)Phase III D)Phase IV 14)Drugs purchased in the United States _______________ drugs in other countries. A)cost twice as much as B)cost three times as much as C)are equal in cost to D)are slightly less than the cost of 15)Gene correction research is being used in the treatment of: A)HIV/AIDS. B)multiple sclerosis. C)SARS. D)Parkinson’s disease. 16)A CT scan is a: A)process used to read the implanted microchip of lost felines. B)computerized axial tomography. C)compound access tomograph. D)computerized access tomography. 17)The medical technology industry employs about _____________ people. A)256,000 B)423,000 C)591,000 D)725,000 18)Gene recombination is: A)swapping an abnormal gene for a normal gene. B)stem cell therapy. C)introduction of a vector virus. D)a translocation of genetic material. 19)All of the following are true about ELSI except: A)it stands for ethical, legal, and social issues. B)in the U.S. the program is part of the Human Genome Project (HGP) budget. C)in the U.S. 3-5% of the HGP budget is devoted to this. D)ELSI is concerned with cost/benefit issues in pharmaceuticals. 20)Which of he following is not true about cost/benefit analysis? A)It compares efficacy of drugs versus devices. B)It compares outcomes to costs of treatments. C)In many countries such an analysis is performed before a technology is adopted by health care professionals. D)The fact that our technology industry is market driven often makes analysis difficult. 21)Medications that consumers can buy for themselves without a prescription are: A)generic drugs. B)over-the-counter drugs. C)investigational drugs. D)disease-specific drugs. 22)Blind randomized trials are: A)new tools which scientists can use to examine millions of compounds a year to screen for good ideas or drug leads. B)phase I research studies. C)phase II research studies. D)studies where volunteers do not know whether they are receiving the drug, a placebo, or standard treatment. 23)All of the following are true about an IND except: A) it is submitted to begin clinical tests on human subjects. B)it is first approved by an Institutional Review Board. C)IND stands for investigational new drug application. D)if it is approved, phase I testing begins. 24)All of the following are ways a new drug is marketed in the United States except: A)medical journals and conference reporting. B)asking the FDA to advertise the drug. C)marketing by drug representatives of pharmaceutical companies. D)reaching patients directly by paid advertising. 25)The FDA does not require the following in direct-to-consumer advertising: A)accuracy. B)claims must be supported by substantial evidence. C)information must reflect a balance of risks and benefits. D)the cost of the drug compared to other drugs must be stated.

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