Scott BassDiane C. McEnroeSarah M. GoldsteinEmily Marden
FDA标准涵盖了多个领域，包括食品、药品、医疗器械、生物制品和化妆品。下面是这些领域的具体标准：2.1 食品安全标准: 食品添加剂: FDA对食品中可使用的添加剂种类、使用量都有明确限定。如防腐剂、着色剂等必须在允许使用的清单之列,且用量不得超过规定限量。农药残留: FDA规定了几百种农药在食品中的残留允许限量...
3. FDA药物注册指南网站(CDER Guidance Documents):https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 这个网站提供了关于药物注册的指南文件,包括注册要求、流程和相关政策。 4. FDA医疗器械注册网站(CDRH Medical Device Registration and Listing):https://www.fda.gov/medical-d...
1 This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2 This guidance applies to drugs, including biological products that are ...
FDA regulates foods, more than 150,000 marketed drugs and medical devices. FDA also regulates cosmetics, animal health products and tobacco products (advertising practices only). At any time, more than 5,000 investigational ne...
FDA regulates foods, more than 150,000 marketed drugs and medical devices. FDA also regulates cosmetics, animal health products and tobacco products (advertising practices only). At any time, more than 5,000 investigational new drugs are under development in around 15,000 INDs, and Advisory Commi...
美国食品药品监督管理局(FDA)于当地时间2月22日,发布了一份新指南草案——"Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance",即"医疗器械使用费小企业资格和认证指南的选择性更新"。 该草案提议2025年开始,有财务困难情况的小微企业可以获得年度注册费(Establis...
CDC relaxes indoor mask guidance, including for schools CA lawmakers introduce bill mandating workplace vaccinations CVS files patent to sell healthcare services in the metaverse News Ending racism in healthcare often begins with medical education - and is the target of a new national project Ine...
(PS:原文标题为《Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions—Guidance for Industry and Food and Drug Administration Staff 》 原文链接文末附上。 因此,《指南》虽不具备法律效力或约束力,但是其中提到的对于医疗器械上市前需提交材料的各种建议,是对于想要...
Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization: ...