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FDAICH指导原则目录.pdf

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CenterForDrugEvaluationand ResearchListofGuidanceDocuments GuidancedocumentsrepresenttheAgency'scurrentthinkingonaparticularsubject. Theydonotcreateorconferanyrightsfororonanypersonanddonotoperateto bindFDAorthepublic.Analternativeapproachmaybeusedifsuchapproach satisfiestherequirementsoftheapplicablestatutes,regulations,orboth.For informationonaspecificguidancedocument,pleasecontacttheoriginatingoffice (seefootnote1inrecentguidances),orcontacttheDivisionofDrugInformationin theOfficeofTrainingandCommunications. OfficeofTrainingandCommunications DivisionofDrugInformation 10903NewHampshireAvenue SilverSpring,MD20993 Telephone:301-796-3400 Fax:301-847-8714 Internet(I):http://www.fda.gov/cder/guidance/index.htm E-mail:druginfo@fda.hhs.gov 110/10/2012 TableofContents(bySubjectCategory) Advertising………………………………………………………………….………..Page3 Biopharmaceutics………………………………………………………….………..Page4 Biosimilarity…………………………………………………………………………...Page5 Chemistry………………………………………………………………….…………Page5 ClinicalAntimicrobial……………………………………………………….…...…..Page9 ClinicalMedical……………………………………………………………………..Page12 ClinicalPharmacology……………………………………………………………..Page19 CMC-Microbiology………………………………………………………………..Page20 CombinationProducts(Drug/Device/Biologic)………………………………….Page20 CurrentGoodManufacturingPractices/Compliance…………………………...Page21 DrugSafety………………………………………………………………………….Page24 ElectronicSubmissions……..……………………………………………………..Page25 GenericDrug………………………………………………………………………..Page27 GoodReviewPractices………………………………..…………………………..Page29 ICH…………………………………………………………………………………...Page29 IND………………………………………………………………………….………..Page38 IndustryLetters……………………………………………………………………..Page38 Labeling……………………………………………………………………………..Page39 ModernizationAct…………………………………………………………………..Page41 OTC……………………………………………………………………………….....Page42 Pharmacology/Toxicology……………………………………………..…………..Page44 Procedural…………………………………………………………………………..Page45 SmallEntityComplianceGuides……………