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 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
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