The U.S. Food and Drug Administration (FDA) has issued a draft guidance for industry regarding the requirement to notify the agency in the case of a permanent discontinuance or an interruption of the manufacture of an infant formula product. FDA Issues 2024 Edition of Voluntary Retail Program ...
引用网址：https://www.foodsafetynews.com/2010/06/kelloggs-recalls-some-popular-cereals/ 另一个例子是2011年, 著名汉堡连锁品牌Burger King被迫从美国和加拿大市场召回数百万个生菜沙拉。原因是FDA检测发现,这些沙拉中存在致病性的沙门氏菌超标。根据FDA标准,沙门氏菌在食品中必须为零存在。这次事件造成Burger Kin...
右侧上方PRODUCTS选项下包括八种类型产品,分别是Food(食品)、Drugs(药品)、Medical Devices(医疗器械)、Radiation-Emitting Products(放射性产品)、Vaccines, Blood, and Biologics(疫苗、血液和生物制品)、Animal and Veterinary(动物和兽医制品)、Cosmetics(化妆品)、Tobacco Products(烟草)。点击任意一项即可快速进入该产...
FDA Considers Expanding Food Ingredient Safety Testing Guidance to New Dietary Ingredients and CosmeticsMansour, Mark
第三级指南(Guidance):由FDA发布的非强制性的建议性文件,用于传达FDA的监管立场和政策 一:法律层面 美国任何一部法律的产生程序是:首先由美国国会议员提出法案,当这个法案获得国会通过后,将被提交给美国总统给予批准,一旦该法案被总统批准(有可能被否决)就成为法律(Act)。当一部法律通过后,国会众议院就把法律的内容...
1 This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. Contains Nonbinding Recommendations II. Background We have seen a growth in the marketplace of beverages and other conventional...
Speaking at an FDApublic meetingcalled "A New Era of Smarter Food Safety," Manders argued that the FDA should examine blockchain vendors, solutions and investment options and provide guidance for enterprises across the food supply chain on how to use blockchain to improve food safety. ...
那么需要遵循FDA“Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)”，“Guidance for Industry and Food and Drug Administration Staff”指南。声明：本文内容部分源于FDA官网信息，中文翻译仅代表汉佛莱（HPC）观点，如有意见或想法，欢迎联系我们或留言，感谢...
FDA在1992年设立了加速批准程序,后续修订成为2012年《食品药品管理局安全与创新法案》(Food and Drug Administration Safety and Innovation Act,FDASIA)的一部分, 允许FDA采用可能预测临床益处(clinical benefit)的合理替代终点或中间临床终点(intermediate clinical endpoint)作为审评依据来加速药物的批准。
or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to Dockets Management Staff (HFA-305), Food and ...