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]Under current federal law, employers are allowed to offer their employees free parking spaces as a tax-free benefit, but they can offer employees only up to $180 per year as a taxfree benefit for using mass transit. The government could significantly increase mass transit ridership by raising the limit of this benefit to meet commuters’ transportation costs. The proposal above to increase mass transit ridership assumes that
A. current mass transit systems are subject to unexpected route closings and delays. B. using mass transit creates less air pollution per person than using a private automobile. C. the parking spaces offered by employers as tax-free benefits can be worth as much as $2,500 per year. D. many employees are deterred by financial considerations from using mass transit to commute to their places of employment. E. (E) because of traffic congestion on major commuter routes, it is often faster to travel to one’s place of employment by means of mass transit than by private automobile. [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 我来回答: 提交
|