^https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-based-pathway ^https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orthopedic-non-spinal-met
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 reg...
SoftwarePoliciesResultingfromSection3060ofthe21stCenturyCuresAct.”4Thisguidancewas mostrecentlyrevisedthroughaLevel2updateinadditiontothedocumentationdescribedin FDA’sfinalguidancetitled“ContentofPremarketSubmissionsforDeviceSoftwareFunctions.”5 Ingeneral,FDA’sguidancedocumentsdonotestablishlegallyenforceableresponsibilit...
FDA定期更新指南,最新版本的指南 ,请查看美国食品药品管理局指南网页https://www. fda. gov/regulatory-information/searchfda-guidance-documents。 该指导原则修订了“评估ANDA透皮和局部给药系统可能的刺激性和致敏性的供企业用的指导原...
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.fda.gov/media...
2022年6月21日 FDA发布指南：“动力粉碎过程中使用的组织遏制系统的非临床性能评估”。组织遏制系统用于在腹腔镜手术后的动力粉碎期间实现人体组织的隔离和遏制，以防止癌组织的扩散。关于该指南的详情可以参考下面的FDA链接：https://www.fda.gov/regulatory-information/search-fda-guidance-documents/non-clinical-...
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 statutory requirements are cited. The use of the word should ...
2022年1月初,FDA先后发布《Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2022》和《CDER Guidance Agenda-New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2022》。本文结合行业发展态势,对这两份文件进行梳理和解读,希望可以为中国制药行业...
2.1 FEATURED左侧FEATURED一栏是关于FDA网站的特色业务介绍,具体如下:(1)Contact FDA介绍如何联系FDA;(2)FDA Guidance Documents可查询指南性文件,如指导原则、法规等;(3)Recalls, Market Withdrawals and Safety Alerts可查询产品的市场召回、撤 销情况;(4)Press Announcements发布的是新闻公告,更新非常及时;(5)Warning...
BPCIA,FDA,FDA Guidance Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents—the draft guidance titled “The ‘Deemed to be a License’ Provision of the BPCI Act Questions...