FDA Food Code - https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/default.htm FDA Facts About Current Good Manufacturing Practices (CGMPs) - https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps FDA Overview of Device ...
定义:FDA注册指的是企业和设施在FDA系统中登记其生产和经营活动,以符合法规要求。FDA注册适用于大部分产品的生产和销售企业。引用FDA官网-食品设施注册:https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions 引用FDA官网-化妆品注册:https:/...
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions 2.事先通知 (1)事先通知的要求 通知时间:必须在宠物食品到达美国边境或进入美国领土前,及时向FDA提交事先通知。根据运输方式的不同,提交事先通知的截止时间有所差异。必需信息:...
A request for an exemption from food allergen labeling can be made either through a petition process or a notification process. See /Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm 395494.htm The petition process requires scientific evidence (including the analytical method used to ...
In support of innovation and more food choices for consumers, in February 2024 the U.S. Food and Drug Administration (FDA) issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants.World Food Regulation Review...
On February 22, 2024, the U.S. Food and Drug Administration (FDA) issued a long-awaited guidance document titled, Guidance for Industry: Foods Derived From Plants Produced Using Genome Editing (Final Guidance). The Final Guidance clarifies FDA’s regulat
点击如下链接可查看强制性食品召回指南原文: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM445437.pdfwww.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM445437.pdf...
您会收到一个确认号,表示注册已经成功提交给 FDA。 关于宠物食品设施注册的更多详细信息,请查看:Registration of Food Facilities and Other Submissions | FDAhttps://http://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions 2...
法规文件数据库的建立需要依托成熟的法律法规体系,美国药品监管法规体系包括法律(Law)、法规(Regulation)和指南文件(Guidance Document)3个层级[7]。FDA网站的数据库不仅涵盖了所有与药品有关的法律法规原文,还将所有技术指南文件纳入其中,供公众免费查询。FDA官方网站自上线运营以来,几经改版,不断更新法律法规数据库,其...
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions 注意事项 必须提交企业注册信息,并同意根据FDA协议随时检查设施 FDA注册前,外国食品企业需要先注册DNUS代码 外国的企业注册FDA,需要有一位美国本土的联系人作为代理 ...