内容提示: Guidance for IndustryChanges to an ApprovedNDA or ANDAQuestions and AnswersU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)January 2001CMC 文档格式:PDF | 页数:14 | 浏览次数:244 | 上传日期:2022-12-07 11:16:43 |...
Guidance for Industry Changes to an Approved NDA or ANDA Q&A 中英对照 Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers
Guidance for Industry Changes to an Approved NDA or ANDA Q&A 中英对照 Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers
系统标签: changes anda supplement effected cder 申报 GuidanceforIndustry ChangestoanApproved NDAorANDA U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) April2004 CMC Revision1 GuidanceforIndustry ChangestoanApproved NDAorANDA Additionalcopiesareavailablefrom...
Changes to anapprovedNDA or ANDA(工艺变更对于申报影响).pdf,Guidance for Industry Changes to an Approved NDA or ANDA U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2004 CMC Re
ChangestoanApproved NDAorANDA 已批准申请的新药变更指南 U.S.DepartmentofHealthandHumanServices FoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER) April2004 CMC Revision1 I.INTRODUCTIONANDBACKGROUND Thisguidanceprovidesrecommendationstoholdersofnewdrugapplications(NDAs)andabbreviatednewdrugapplications(...
GuidanceforIndustryChangestoApprovedNDAorANDA已批准申请的新药变更指南U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)April2004CMCRevision1INTRODUCTIONANDBACKGROUNDThisguidanceprovidesrecommendationstoholdersofnewdrugapplications(NDAs)andabbreviatednewdrugapplications(ANDAs...
ChangestoanApproved NDAorANDA 已批准申请的新药变更指南 U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministration CenterforDrugEvaluationandResearch(CDER)April2004CMC Revision1 I.INTRODUCTIONANDBACKGROUND Thisguidanceprovidesrecommendationstoholdersofnewdrugapplications(NDAs)andabbreviatednewdrugapplications(ANDAs)...
Guidance for Industry on Changes to an Approved NDA or ANDA; AvailabilityJeffrey Shuren
Guidance for Industry Changes to an Approved NDA or ANDA Q&A 中英对照 Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers