近期,FDA官网发布《Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2025》,对FDA下属CDER将在2025年发布的指南,进行了介绍。详情参见下表。 第二部分:CBER 2025年指南工作计划重点介绍 下面对这份2025年技术指南工作...
3. FDA. Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-submitting-proposed-draft-guidance-relating-patient...
“Many of these draft guidances were not finalized … because of higher priorities and resource issues,” according to the announcement. The agency noted that new information and emerging technologies have made these draft documents outdated.
请参阅 FDA 的指导文件《Q7 原料药生产质量管理规范指南》,了解有关原料药生产质量管理规范的指导,网址是 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients。 Conclusion 结论 The deviations cited in...
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（...
FDA last week published a guidance document on a notification requirement in DSHEA that is perhaps more important than ever in the law's 30-year history.
1FDA,Psychedelic Drugs: Considerations for Clinical Investigations, Guidance for Industry, Draft Guidance(June 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations.
[2] Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway. Retrieved January 7, 2025, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accelerated-approval-and-considerations-determining-whether-confirmatory-trial-underway ...
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity. FDA released final guidance documents on biosimilar products on Apr. 28, 2015. The three documents are: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in ...
24 Jan 2025 What You Need to Know In September 2024, the FDA issued the Draft Guidance "Chemical Analysis for Biocompatibility Assessment of Medical Devices Draft Guidance for Industry". In this document, the FDA provides recommendations for analytical chemistry testing to evaluate the biocompatibilit...