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)这里提供一个方便的方法,从一个入口搜索所有的FDA相关的指导文件,例如:重点查看CGMP和CMC相关的指南更新情况: 3、Recalls, Market Withdrawals, & Safety Alerts 可查询产品的召回、撤市和安全警报等情况;召回、撤...
(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 Letters可查询FDA开出的警告信; (6)Advisory Committees可查询咨询委员会的工作情况; (7)En...
以上8个模块,常用的是(2)Drug Approvals and Databases药品批准情况和数据库(3)Drug Development and Review Process药品开发和审评流程(4)Guidance, Compliance, and Regulatory Information:指南、合规性和监管信息(7)Updates, News, Events, and Training新的审评进展、新产品和新培...
So far, stakeholder andother regulatory advisory committeeshave used their discretion when evaluating the clinical utility and appropriateapplications of digital health technologies. However, having a dedicated team to address these issues can provide more explicit guidance and standardized protocols. ...
PIC/S Issues Guidance on Remote and Hybrid Inspections 2024年12月17日，药品检查合作计划（PIC/S）发布了两份新文件，以规范各成员国远程与混合检查的规划、执行和后续工作。这些文件由PIC/S远程评估工作组制定，该工作组由澳大利亚治疗用品管理局（TGA）的Jenny Hantzinikolas领导，于11月15日获批，将于2025年1...
With Five Guidances, FDA Prepares For Advisory Committee OverhaulJessica Bylander
(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 Letters可查询FDA开出的警告信;(6)Advisory Committees可查询咨询委员会的工作情况;(7)En ...
总的来说，这份指南旨在通过为药物申办方和其他利益相关者明确FDA如何评估新药和生物制品的获益和风险，确保监管决策是透明的、一致的和科学严谨的。同时，为了增加FDA指南文件的透明交流和传播，提高公众对指南文件的认识和参与，FDA 正在启动指南快照试点（Guidance Snapshot Pilot）项目。本期分享的指南回顾播客（...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-focused-drug-development-incorporating-clinical-outcome-assessments-endpoints-regulatory 药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务,服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及...
" "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are ...