Changes Being Effected to Drug Labeling Regime: FDA Releases Proposed Pathway for Generic Safety UpdatesBerman, Jonathan
在FDA的申请信批准中 Prior Approval 和 Changes Being Effected 这两个词的官方翻译是什么呢？
FDA has conveyed additional clarification regardingreporting of CMC changes to an NDA, BLA, and ANDA in guidance documentsspecific to various application types and product dosage forms (see sectionVII., References). The content in section IV., Common Changes Related to GlassVials and Stoppers, rela...
药物依赖、心理反应或药物过量的说明;③为药品的安全使用而增加或强调用法用量的说明;④删除错误的、具有误导性的或不支持药品适应症或功效的信息;⑤FDA特别要求的在药品销售之前提交并获得批准的标识变更,针对以上情况FDA设定了特殊类型的补充申请——立即生效补充申请(changes being effected-0,CBE-0),即申请人...
(ii)).Guidanceonchangesincomponentsandcompositionthatmaybesubmittedinachanges-being-effectedsupplementorannualreportisnotincludedinthisdocumentbecauseofthecomplexityoftherecommendations,butmaybecoveredinoneormoreguidancedocumentsdescribingpostapprovalchanges(e.g.,SUPACdocuments).处方质量或数量改变,包括费活性成分,认为是...
suchastheSUPACguidances,stillapply.Section506AoftheActand§314.70(c)providefortwotypesofchanges-beingeffectedsupplements(seesectionII),whilepreviouslytherewasonlyonetype.Itisimportantforapplicantstousethisguidancetodeterminewhichtypeofchanges-being-effectedsupplementisrecommended.CDERintendstoupdatethepreviously...
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...
FDA at least 30 days before the distribution of the drug product made using the change.This type of supplement is cal led,and should be clearlylabeled,a Supplement-Changes Being Effected in 30 Days(§314.70(c)(3)).The drug product made using a moderate change cannot be distributed if FDA...