| 查看: 890 | 回复: 0 | |||
[交流]
美国FD&C Act对New drug的定义怎样理解？
|
|
The term "new drug" means— (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. |
回复此楼» 猜你喜欢
维普求助
已经有0人回复
-
美国杜兰大学医学院Dr. Yan Dong实验室招聘
已经有13人回复
-
药物学论文润色/翻译怎么收费?
已经有190人回复
-
求计算药动学参数
已经有0人回复
-
细胞死亡新方式：铜死亡
已经有9人回复
-
丙酮酸激酶的抑制剂和激动剂
已经有1人回复
-
脓毒症（盲肠结扎）
已经有22人回复
-
这个自发加氧反应的机理是什么？
已经有7人回复
-
看过往病历，有疑惑请教
已经有3人回复