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...
Your response is inadequate. Your response does not include a comprehensive assessment into employees creating new records to correct errors, and you do not identify the root cause or scope of the “errors” made with potential impact to CGMP document...
[1] Considerations for the Use of Human and Animal Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products (April 2024)https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-...
1 指南会定期更新，详见FDA官网https://www.fda.gov/regulatory-information/search-fda-guidance-documents 2 更换玻璃供应商，但不改变玻璃类型或涂层，也不改变容器/封口尺寸，可作为年报递交，详见指南CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports (March 2014) 附录中的5.4章节。3 ...
为反映相关信息的不断发展和高度技术性，FDA将在此网页上提供与本指南有关的某些更新信息(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cder-nitrosamine-impurity-acceptable-intake-limits)。具体来说，FDA计划在该网页上提供以下方面的最新信息：(1) 根据亚硝胺杂质的预测致癌性分类（...
2024财年FDA会新发布/更新哪些指南? CDRH Proposed Guidances for Fiscal Year 2024(FY2024) The lists on this page include guidance documents the FDA’s Center for Devices and Radiological Health (CDRH) intends to publish this fiscal year (FY2024), as well as previously-issued final guidances for...
在完整回复（CR）或临时批准（TA）之后进行的增补（Amendment）、补充申请（Supplement）及其增补，均不适用于15个月的宽限期。●指南原文链接：https://www.fda.gov/regulatory-information/search-fda-guidance-documents/facility-readiness-goal-date-decisions-under-gdufa ...
2024年3月7日,恒瑞医药递交了相关说明文件。但经过审查,FDA认为不足以解释问题,最终在7月发出警告信。 1 质控部门未能履行其职责 FDA声称,恒瑞医药的质量控制部门未能履行其职责,确保生产的药品符合CGMP标准,并符合既定的特性、强度、质量和纯度规范(21 CFR 211.22)。
实际上,FDA在今年9月份时已公布了仿制药PSG修订计划,涉及八百多个仿制药的BE各论,主要为了免除餐后BE研究的要求,这无疑对业内的影响是巨大的,可以关注。 指南原文链接 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m13a-bioequivalence-immediate-release-solid-oral-dosage-forms...
1. 定期监控FDA的最新发布 主动获取信息：订阅FDA更新：FDA经常发布新的指南、政策声明和法规更新。通过订阅FDA的电子邮件通知和RSS订阅，企业可以第一时间获取这些信息，确保不遗漏任何重要更新。浏览FDA官网：定期访问FDA官网的“Guidance Documents”页面和“New and Updated”栏目，了解最新发布的指南和政策变化。尤其要...