In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statu...
FDA指南2023版本的下载地址: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and FDA指南2020版本的下载地址: https://www.fda.gov/media/85865/download Use of International Standard ISO ...
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2023 Final Guidance Topics • Peroxide-Based Contact Lens Care Products – Patient Labeling Recommendations 过氧化氢隐形眼镜护理产品-患者标签建议 Draft Guidance Topics • Chemical Analysis for Biocom...
参考文件如下: 1. FDA. Post-Warning Letter Meetings Under GDUFA. September 2023,https://www.fda.gov/regulatory-information/search-fda-guidance-documents/post-warning-letter-meetings-under-gdufa 2. FDA.GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027.https://www....
近期,FDA发布了《Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024 (Updated January 2024)》,对2024年度生物制品技术指南修订和制定工作做出明确要求。本文将对FDA在2023年1月和6月两次发布的指南制定计划...
/regulatory-information/search-fda-guidance-documents. 7最终,ICHQ12实施指南将代表FDA目前对这一主题的想法。有关指南的最新版本,请访问FDA指南网页/regulatory-information/search- fda指导文件. DateofIssuance:01/27/2023Page10of50 PROGRAM7356.843 Forexample,anychangetoanestablishedcondition(EC)—legallybindinginf...
FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
4. Guidance for Industry: Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products, April 1996,https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstration-comparability-human-biological-products-including-therapeutic-biotechnology-de...
示例1显示了NDSRI,即N-Nitroso-L-nebivolol的活性指数计算方法: 示例2的NDSRI为N-nitroso-ketamine 原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related...
A pair of guidance documents, one of them a draft and one in its final form, were published by FDA on Jan. 7, 2025 (1,2). The deadline for comments on the draft guidance to be considered for its final version has been set for April 8, 2025 (2). That guidance, “Developing Drug...