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发布时间:2024-07-05 22:21:13

[单项选择]Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiveness have been demonstrated and of which the Food and Drug Administration (FDA) has approved, or socalled "approved uses." Other uses have come to be called "unapproved uses" and cannot be legally promoted. In a real sense, the term "unapproved" is a misnomer because it includes in one phrase two categories of marketed drugs that are very different; drugs which are potentially harmful and will never be approved, and already approved drugs that have "unapproved" uses. It is common for new research and new insights to demonstrate valid new uses for drugs already on the market. Also, there arc numerous examples of medical progress resulting from the serendipitous observations and therapeutic innovations of physicians, both important methods of discovery in the field of therapeutics. Before such advances can result in new indications for inclusion in drug labeling,
A. has been reviewed by the FDA and specifically rejected
B. has medical value but has not yet been approved by FDA for inclusion as a labeled use
C. is authorized by the label as approved by the FDA on the basis of scientific studies
D. is made in experiments designed to determine whether a drug is medically beneficial

更多"Under existing law, a new drug may "的相关试题:

[单项选择] Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiveness have been demonstrated and which the Food and Drug Administration (FDA) has approved, or so-called approved uses. Other uses have come to be called "unapproved uses", and cannot be legally promoted. In a real sense, the term "unapproved" is a misnomer because it includes one phrase two categories of marketed drugs that are very different. It is common for new research and new insights to identify valid new uses for drugs already on the market. Before such advances can result in new indications for inclusion in drug labeling, however, the available data must meet the legal standard of substantial evidence derived from adequate and well-controlled clinical trials. Such evidence may require time to develop, and, without initiative on the part of the drug firm, it may not occur at all for certain uses. However, because medical literature on new uses exi
A. refute a theory
B. draw a distinction
C. condemn an error
D. describe a new development
[单项选择]
TEXT B

Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiveness have been demonstrated and of which the Food and Drug Administration (FDA) has approved, or socalled "approved uses." Other uses have come to be called "unapproved uses" and cannot be legally promoted. In a real sense, the term "unapproved" is a misnomer because it includes in one phrase two categories of marketed drugs that are very different; drugs which are potentially harmful and will never be approved, and already approved drugs that have "unapproved" uses. It is common for new research and new insights to demonstrate valid new uses for drugs already on the market. Also, there arc numerous examples of medical progress resulting from the serendipitous observations and therapeutic
[单项选择]
{{B}}TEXT A{{/B}}

Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiveness have been demonstrated and of which the Food and Drug Administration (FDA) has approved, or so-called "approved uses." Other uses have come to be called "unapproved uses" and cannot be legally promoted. In a real sense, the term "unapproved’ is a misnomer because it includes in one phrase two categories of marketed drugs that are very different; drugs which are potentially harmful and will never be approved, and already approved drugs that have "unapproved" uses. It is common for new research and new insights to demonstrate valid new uses for drugs already on the market. Also, there are numerous examples of medical progress resulting from the serendipitous observations and therapeutic innovations of physicians, both important methods of discovery in the field of therapeutics. Bef
A. refuting a theory
B. drawing a distinction
C. discrediting an opponent
D. condemning an error
[填空题]Under the new law, if a boss forces his worker to take a polygraph test, what punishment will he get


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