首页
外语
计算机
考研
公务员
职业资格
财经
工程
司法
医学
专升本
自考
实用职业技能
登录
外语
Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiven
Under existing law, a new drug may be labeled, promoted, and advertised only for those conditions in which safety and effectiven
admin
2011-02-11
47
问题
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, 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 exists and these uses arc medically beneficial, physicians often use these drugs for such purposes prior to FDA review or changes in labeling. This is referred to as "unlabeled uses" of drugs.
A different problem arises when a particular use for a drug has been examined scientifically and has been found to be ineffective or unsafe, and yet physicians who either are uninformed or who refuse to accept the available scientific evidence continue to use the drug in this way. Such use may have been reviewed by the FDA and rejected, or, in some cases, the use may actually be warned against in the labeling. This subset of uses may be properly termed "disapproved uses."
Government policy should minimize the extent of unlabeled uses. If such uses are valid—and many are—it is important that scientifically sound evidence supporting them be generated and that the regulatory system accommodate them into drug labeling. Continuing rapid advances in medical care and the complexity of drug usage, however, makes it impossible for the government to keep drug labeling up to date for every conceivable situation. Thus, when a particular use of this type appears, it is also important, and in the interest of good medical cure, that no stigma be attached to "unapproved usage" by practitioners while the formal evidence is assembled between the time of discovery and the time the new use is included in the labeling. In the case of "disapproved uses," however, it is proper policy to warn against these in the package insert, whether use of a drug for these purposes by the uninformed or intransigent physician constitutes a violation of the current Federal Food, Drug and Cosmetic Act is a matter of debate that involves a number of technical and legal issues. Regardless of that, the inclusion of disapproved uses in the form of contraindications, warnings and other precautionary statements in package inserts is an important practical deterrent to improper use. Except for clearly disapproved uses, however, it is in the best interests of patient care that physicians not be constrained by regulatory statutes from exercising their best judgment in prescribing a chug for both its approved uses and any unlabeled uses it may have.
According to the passage, an unlabeled use of a drug is any use which ______.
选项
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
答案
C
解析
细节判断题。在文章第一段中,unlabeled use指任何已被FDA批准使用的药品,它的某种医疗作用还未被 FDA所确认,因此C是正确答案。A的内容不正确,因为它指的是被文明规定禁止的用途。B的内容是错误的,unlabeled use指的是当初该药品被批准使用时还未曾考虑到的用途,但是在以后的使用过程中被发现了,事后因时间关系未曾被官方提出过,也未曾测试过,也未曾否定过。D的内容也是错误的,如果是这样的话,作者一定会认为这是labeled use。
转载请注明原文地址:https://kaotiyun.com/show/OpeO777K
0
专业英语八级
相关试题推荐
TheRomanticwritersintheAmericanliteraryhistoryfocusedonallthefollowingissuesEXCEPT
TheRiseofRPHistoricalreasonsReceivedPronunciation(RP)wasoriginallyassociatedwitha______【1】spokenintheregion
Anumberoffactorsrelatedtothevoicerevealthepersonalityofthespeaker.Thefirstisthebroadareaofcommunication,wh
根据“十五”期间的形势和任务,《纲要》提出今后五年经济和社会发展的主要目标是:国民经济保持较快发展速度,经济结构战略性调整取得明显成效,经济增长质量和效益显著提高,为到2010年国内生产总值比2000年翻一番奠定坚实基础。国有企业建立现代企业制度取得重大进
Professionalwomenwhoputcareersonholdforfamilyorotherreasonsearnispercentlessoncetheyreturntotheworkforce,a
WeliveinsouthernCaliforniagrowinggrapes,afirstgenerationofvintners,ourhomeadjacenttothevineyardsandthewinery
Thecinemahaslearnedagreatdealfromthetheateraboutpresentation.Gonearethedayswhencrowdswerepackedonwoodenben
______istheauthorofScarletLetter.
A、therewillbenomorefightsamongVietnameserefugeesB、conditionsatthecampwillbeimprovedC、thecampresidentswillbe
A、Eachplayerhas2knights,aKing’sKnightandaQueen’sKnight.B、TheKnightistheonlypiecewhichcanjumpoverpieces.C、
随机试题
Tocultivatecommunicativecompetence,whatshouldcorrectionfocuson?
对DIC病人早期进行抗凝治疗时,首选的药物是
A.斑片状肺不张B.压迫性肺不张C.收缩性肺不张D.盘型肺不张E.阻塞性肺不张患者,女,16岁。右上支气管结核,经抗结核治疗9个月,右上叶体积缩小伴纤维条索影,应属于何种肺不张
对于易水解的药物,最适宜的剂型为()
出现游走性关节疼痛、痛无定处的原因是()
矿业工程注册建造师执业工程范围包括()。
人民检察院、人民法院和公安局都是国家的司法机关。()
下列关于爱岗敬业的说法中,你认为不正确的是()。
①山下的石头堡垒,是敌人为了______我游击队袭击而新近建立的。②巴金永远是那样______而亲切地向读者表白自己的思想。③不断______这种电子蛙眼,就可以准确地把预定搜索的目标同其他物体分开。依次填入划横线处的词语,最恰当的
Notuntilmostofthepeoplehadleftthemeetingroom______hissisterwasthere.
最新回复
(
0
)