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1、GuidanceforIndustryDrugSubstanceChemistry,Manufacturing,andControlsInformationDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin180daysofpublicationintheFederalRegisterofthenoticeannounci
2、ngtheavailabilityofthedraftguidance.SubmitcommentstoDocketsManagementBranch(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsrega
3、rdingthisdraftdocumentcontact(CDER)StephenMiller(301)827-2392,(CBER)ChrisJoneckis(301)435-5681,or(CVM)DennisBensley(301)827-6956.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandReview(CBER)Centerf
4、orVeterinaryMedicine(CVM)January2004CMCE:file-serverfs_tmpdownload281dd8300708ec8b40cc35ddd0f64e45.doc06/21/21GuidanceforIndustryDrugSubstanceChemistry,Manufacturing,andControlsInformationAdditionalcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation
5、,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573http://www.fda.gov/cder/guidance/index.htmorOfficeofCommunication,TrainingandManufacturersAssistance,HFM-40CenterforBiologicsEvaluationandResearchFoodandDrugAdministr
6、ation1401RockvillePike,Rockville,MD20852-1448http://www.fda.gov/cber/guidelines.htm.(Tel)VoiceInformationSystemat800-835-4709or301-827-1800orCommunicationsStaff,HFV-12CenterforVeterinaryMedicineFoodandDrugAdministration7519StandishPlaceRockville,MD20855(Tel)301-827-3800http://www.f
7、da.gov/cvm/guidanc/published.htmU.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandReview(CBER)CenterforVeterinaryMedicine(CVM)January2004CMCE:file-serverfs_tmpdownload281dd8300708ec8b40cc35ddd0f
8、64e45.doc06/21/21ContainsN
