Text B How Does FDA Approve New Drugs?
Under current law, all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. But it’s important to realize that no drug is absolutely safe. There is always some risk of an adver reaction. It’s when the benefits outweigh the risks that FDA considers a drug safe enough to approve.
1.outweigh [autˊweɪ] vt. 在重量上超过；在重要性或价值方面超过
根据现行法规，对于所有新药，只有经确认安全、有效，才会被批准上市。但是，我们应该意识到没有所谓绝对安全的药物，认识到这一点是很重要的。任何药物都可能有不良反应。因此，只有认定某种药物的益处大于其风险时，FDA才会认为某种药物足够安全，可批准其上市。
In fact, it was only 25 years ago that U.S. drug law first embraced the idea of risk vs. benefit that now the key to new drugs approval. Providing evidence of safety before marketing was first required by Federal Food, Drug and Cosmetic Act in 1938, but not until the Drug Amen
dments of 1962 did firms also have to show a drug’s effectiveness before marketing. Before any drug gets on the market today, FDA decides—as quickly as a thorough evaluation allows—whether the studies submitted by the drug’s sponsor(usually the manufacturer) show it to be safe and effective for its intend u.
电池充不进电1.embrace [im'breis] vt. 清明节英语包括; 包含；接受；信奉, 皈依
vt. & vi. 拥抱n. 拥抱, 怀抱
2.cosmetic [kɔz'metik] n. 化妆品 adj. 化妆用的; 美容的；装点门面的
Federal Food, Drug and Cosmetic Act联邦食品、药品和化妆法案
3.Drug Amendments [ə'mendmənts] 药品法修正案
4.thorough ['θʌrəu] adj. 彻底的；十足的；考虑周到的
5.sponsor ['spɔnsə] vt. 赞助, 发起, 主办n. 申办者
事实上，直到25年前美国药品管理法才刚刚引入“风险-益处评估”的概念。但是，现今，某种药物能否获批上市取决于“风险-益处评估”的结果。1938年颁布的联邦食品、药品和化妆品法首次规定在新药上市前，申办者需提供可证明药物安全性的资料，但直到1962年的药品法修正案才要求申办者同时提供可证明药物有效性的资料。现今，FDA首先要对新药申办者（通常是制药公司）提供的资料进行深入、彻底的评估，尽快判断这些资料可否证明药物在用于其申报的适应症时安全、有效，最后决定是否批准该药上市。
Promising Experimental Drugs
In May 1987, FDA published a regulation to allow broader u of promising experimental drugs such as zidovudine so that desperately ill and dying patients can receive the benefits of tho drugs years earlier than was possible before. Promising is the key word in this broadened u of unapproved drugs. FDA can’t allow drugs to be ud haphazardly. “It’s a disrvice.” says FDA medical officer Alexander Fleming, M.D., “to let even a dying patient u an unproven drug unless qualified physicians believe it has some chance of helping. That only rais fal expectations and might cau needless s
uffering or hasten death. A “try anything法宣在线学习登录” approach prevents physicians from quickly learning whether a drug works, and that’s a disrvice to other similarly ill who could be helped by an effective drug.” In other words FDA requires that experimental drugs, too, satisfy a certain benefit-to-risk ratio.
1.zidovudine电脑上怎么打字 [zi'dɔvjudi:n] n. 齐多呋定
2.desperately ['despərɪtlɪ] adv. 绝望地;不顾一切地,拼命地；
3.haphazardly [‚hæp'hæzɚdlɪ]最美的情话 adv. 偶然地;随意地;杂乱地
4.disrvice ['dis'sə:vis] 符号大全花样符号n. 伤害,虐待,不亲切的行为
5.hasten ['heɪsən] vt. & vi. 加速;催促;赶快
1987年5月，FDA颁布了一项法规，放宽了诸如齐多夫定之类的具有重大治疗价值的、处于实验阶段的药物的使用范围，以便重病或濒死患者可以尽早获益。按照常规的审批程序，数年后这些药物才可上市，供患者使用。具有重大治疗价值是放宽处于审批阶段药物
使用范围的前提。FDA不会允许患者在没有专业人士指导的前提下随意用药。FDA医药部的官员，医学博士Alexander Fleming指出：即使是对于濒死的患者，也要经医生认可才能使用实验阶段的药物，否则结果可能不堪设想。随意用药往往只是让患者空欢喜一场，或者让患者遭受不必要的痛苦或导致其猝死。对于医生而言，病急乱用药的方法使其无法迅速获知某种药物是否有效。这对患有此类疾病的患者而言是个不利的，原本他们可能使用有效的药物而受益。换言之，对于实验阶段的药物，FDA也要进行“风险－益处评估”才会决定是否放宽其使用范围。
So, FDA reviewers scrutinize massive amounts of information in NDAs to evaluate the effectiveness and safety of new drugs. A drug is first reviewed, however, when a sponsor submits an investigational new drug application (IND) to FDA before tests with people begin. Within 30 days, FDA must let the sponsor know whether, in its judgment, the propod test is sufficiently safe. If so, the IND is considered to be “in effect” and the clinical史上最难最变态绕口令 study may proceed; if not, FDA may place the study on hold until the sponsor makes needed changes.
1.reviewer [rɪ'vju:ə] n. 评论家
2.scrutinize ['skru:tn,aɪz] vt. 仔细检查,详审
因此FDA的审评员要仔细研究新药注册申报资料中的大量数据，以评价新药的安全性和有效性。但是，FDA对新药的评审是从审查新药临床研究申报资料开始的，这些资料由申办者递交。在收到资料后30天内，FDA需要告知申办者其递交的试验资料能否证明药物的安全性。如能证明药物的安全性，FDA认为新药临床前研究结果有效，可以批准申办者进行新药临床研究；否则暂不允许申办者进行新药临床研究，直到其补充的临床前研究资料达到要求。
Sponsors are encouraged to meet with FDA before the final pha of human test, which are the large-scale controlled clinical trials. At this conference, FDA gives advice about the design of the sponsor’s study plan to ensure that the trials will be acceptable. FDA’s Temple puts it: “We have the experience of finding and eliminating flaws in the plan that we know will give us trouble later on in the NDA review. We don’t want people to carry out a large study that have no chance of being considered adequate and well-controlled.”
1.trial ['traiəl] n. 审判, 审理；测试, 试验, 考验；
2.flaw [flɔ:] n. 缺点, 瑕疵, 缺陷
FDA鼓励申办者在进行三期临床试验之前与其交流，召开沟通会。会议上，FDA的有关人员对申办者的研究方案提出建议，确保临床试验的结果能达到FDA的要求。就此，FDA的Temple有如下评论：我们对如何设计研究方案有丰富的经验，可以发现和消除申办者实验计划中的漏洞，以免其给我们后续的新药注册申报资料评审工作带来麻烦。我们不希望申办者在计划不周时就匆忙的开展大规模的临床研究，这样的研究几乎不可能做到全面和充分对照。
Review time
国培研修计划On the date FDA receives an NDA, a “review clock” is started: by law, FDA has 180 days to review the application and either approve or reject it. The span from “day 1” to “day of approval” is almost always longer than 180 days, however, both becau the initial review takes longer than that and becau it is usually necessary to carry out more than one review to resolve issues raid by the information initially submitted. Average approval time, in fact, is more like two years.
1.initial [i'niʃəl] adj.最初的, 开头的
2.resolve [ri'zɔlv] vt. & vi. 决定; 决心
