1、201006 FDA行业指南 可在年报中报告的CMC已批准生产变更草案(中英文) 2013-01-22 16:04:09| 分类: FDA|字号 订阅 Guidance for Industry行业指南CMC Postapproval Manufacturing Changes Reportable in Annual Reports可在年报中报告的CMC已批准生产变更DRAFT GUIDANCE指南草案This guidance document is being ...
FDA的策略是评估器械产品的整体生物相容, 而不是产品的某一部分。评估包括原材料,原材料处理,生产工艺以及生产过程遗留的微量成分。FDA强烈建议阅读FDA 对于ISO 10993-1的指导文件:FDA’s Biocompatibility Guidanceon Use of ISO 10993-1 通常,FDA感兴趣的生物相容性因素为: ...
An applicant should consider all relevant CDER guidance documents for recommendations on the information that should be submitted to support a given change.4 作为可能关系到药品安全性和有效性的以下因素,药品的特征、剂量(例如含量测定、含量均一性)、 质量(例如,物理、化学和生物学特性) 、纯度(例如,杂质...
other postapproval change CMC guidances (see Section V. Resources for a list of those guidances...
Additionally, the draft guidance provides a 'Questions and Answers' section on CPs in the Appendix, which covers general questions and questions regarding formulation, manufacturing site and process, specification (including analytical methods), packaging, and process analytical technology (PAT) changes. ...
FDA-溶出度指导原则.pdf,Guidance for Industry Q8 Pharmaceutical Development U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) May 20
For FTP, connect to the CDER anonymous FTP server at CDVS2.CDER.FDA.GOV and change to the “guidance” directory. For Gopher, connect to the CDER Gopher server at GOPHER.CDER.FDA.GOV and select the “Industry Guidance” menu option. For WWW, connect to the FDA Home Page at WWW.FDA....
Itdoes,haJever, offerguidancem acceptablea~caches tomeetingregulatoryrequiremnts. Different approaches naybe fol.lowed,buttheapplicautis encouraged to discuss significant variations in advance with m reviewers to preclude expmding time andeffortinpreparinga submissim that FDA may later determine to be ...
EPA next plans to address the scope of plant regulator PIPs and update its 2007 guidance on small-scale field testing of PIPs to reflect technological developments and harmonize with USDA containment measures. Regarding modified animal products, EPA intends to work with USDA and FDA to coordinate ...
PAGE PAGE 2 GuidanceforIndustry ContainerClosureSystemsforPackagingHumanDrugsandBiologics Chemistry,ManufacturingandControlsDocumentation 行业指南人用药品及生物制品的包装容器和封装系统:化学,生产和控制文件指南发布者:美国FDA下属的CDER及CBER 发布日期:May1999 TABLEOFCONTENTS目录 INTRODUCTION介绍 BACKGROUND 背景 ...