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单词 Premarket Notification
释义

Premarket Notification

中文百科

联邦食品、药品和化妆品法案 Federal Food, Drug, and Cosmetic Act

(重定向自Premarket Notification)
美国官方大纹章

美国联邦食品、药品和化妆品法案(常缩写为FFDCAFDCA,或FD&C)是美国国会在1938年通过的一系列法案的总称,赋予美国食品药品监督管理局(FDA)监督监管食品安全、药品、及化妆品的权力。该法案主要是由Royal S. Copeland写成,其为一三年期的纽约州参议员。该法案通过后又历经多次修改。

催生该法案的主要原因之一是因为一种磺胺药物中所使用的溶剂二甘醇导致100多名病人死亡。这部法案诞生后取代了1906年通过的纯净食品及药品法案

英语百科

Federal Food, Drug, and Cosmetic Act 联邦食品、药品和化妆品法案

(重定向自Premarket Notification)
Great Seal of the United States

The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

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更新时间:2025/6/18 20:15:47