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1、眼科常見病及護(hù)眼保健.IntegratedSummariesofImmunogenicity: AnFDAReviewer’sWishListDisclaimerViewsexpressedinthispresentationarepersonal,andreflectiveofmyexperienceasanimmunogenicityreviewerfortheOfficeofBiotechnologyProducts.MyviewsarenotnecessarilyreflectiveofviewsorcurrentpoliciesoftheFDA.The“Integrated
2、SummaryofImmunogenicity”isoptionalforBLAsFDAmayincludeanISIrecommendationinnewversionof2016guidanceImmunogenicityattheFDAWhoreviewsit?DependsontheclassofproductCDER-monoclonalantibodies,growthfactors,fusionproteins,cytokines,enzymes,therapeutictoxinsCBER-allergenics,bloodandbloodcomponentsinclu
3、dingclottingfactors,cellularandgenetherapies,vaccinesOfficeofBiotechnologyProducts(OBP)CMCfor351(a)and351(k)biologicsunderCDERpurviewCurrently4productdivisionswithmixedportfoliosCollaborateinimmunogenicityriskassessmentsandreviewvalidationofclinicalimmunogenicityassaysfor351(a)and351(k)biologic
4、satCDERInvolvedinwritingFDAImmunogenicityguidancesImmunogenicityWorkingGroupFDAImmunogenicityGuidancesGuidance(2014):ImmunogenicityAssessmentforTherapeuticProteinProductDiscussesproductandpatientriskfactorsthatmaycontributetoimmuneresponserates.DraftGuidance(2016):AssayDevelopmentforImmunogenic
5、ityTestingofTherapeuticProteinsDiscussesthedevelopmentandvalidationofimmunogenicityassaysGuidance(2016):Immunogenicity-RelatedConsiderationsforLowMolecularWeightHeparinProvidesrecommendationsonaddressingimpuritiesandtheirpotentialeffectonimmunogenicityforANDAsGuidance(2015):ScientificConsiderat
6、ionsInDemonstratingBiosimilarityToAReferenceProductDiscussesimmunogenicityassaysincontextof351(k)pathwayGuidance(2017):ConsiderationsinDemonstratingInterchangeabilitytoaReferenceProductDiscussesimmunogenicitystudiesrequiredforinterchangeabilityincontextof351(k)pathwayDraftGuidance(2017):ANDAsfo
7、rCertainHighlyPurifiedSyntheticPeptideDrugProductsThatRefertoListedDrugsofrDNAOriginDiscussesimmunogenicityconsiderationsforrecombinantpeptidesunderANDACDERImmunogenicityReview CommitteeIRCisanewcross-centercommitteewithmembersfro
