How_FDA_Approves_New_Drugs.ppt

（A）：形容词后缀 -ic 高价金属和正酸词尾 -ous 低价金属和亚酸词尾 （B）：名词性后缀 -ate 正酸盐词尾 -ite 亚酸盐词尾 -ide 无氧酸盐词尾 chlorate 氯酸盐 chlorite 亚氯酸盐 chloride 氯化物 nitrate 硝酸盐 nitrite 亚硝酸盐 nitride 氮化物 borate 硼酸盐 borite 亚硼酸盐 boride 硼化物 sulfate 硫酸盐 sulfite 亚硫酸盐 sulfide 硫化物 phosphate 磷酸盐 phosphite 亚磷酸盐 phosphide 磷化物 carbonate 碳酸盐 carbonite 碳质炸药（硝化甘油） carbonide 碳化物 * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * FDA then writes the applicant to say either that the drug is approved for marketing, is approvable provided minor changes are made, or is not approvable because of major problems. In the last case, the applicant can then amend or withdraw the NDA or ask for a hearing. Once its NDA is approved, a drug is on the market as soon as the firm gets its production and distribution systems going. FDA approves about 75 percent of all the NDAs submitted. Page 251， Line 19 amend 修正 withdraw 撤回 Page 251， Line 21 distribution system 分布系统，流通系统 get going：to make a beginning; get started. 起头；开始 Most prescription and over-the-counter (OTC) drugs that were on the market before the Federal Food, Drug and Cosmetic Act was passed in 1938 are “grandfathered”. That means they are allowed on the market without the stringent proof of safety and effectiveness required of later drugs. Thus, FDA has not reviewed every single drug sold in the United States. Page 251， Line 23 prescription 处方药 over-the-counter （OTC）(药物)不需处方但可合法出售的 Page 251， Line 25 stringent 严格的 As new challenges arise, FDA drug review will no doubt continue to evolve. A vital part of that evolution, is strengthening FDA’s science base. evolve (使)发展, (使)进展, (使)进化 evolution 进展, 发展, 演变, 进化 * * * * * * * * * * * * * * * * * * * * * * * * * * * 如果数据来自国外，FDA需要了解： FDA是否能以检查或其他方式证明这些数据的有效性？ 这些信息是否适用于美国人群和行医方式？国家之间的