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ProcessesandPractices
Applicableto
BioresearchMonitoring
Inspections
GuidanceforIndustry
DRAFTGUIDANCE
Thisguidancedocumentisbeingdistributedforcommentpurposesonly.
Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysof
publicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraft
guidance.Submitelectroniccommentsto.Submitwritten
commentstotheDocketsManagementStaff(HFA-305),FoodandDrugAdministration,5630
FishersLane,Rm.1061,Rockville,MD20852.Allcommentsshouldbeidentifiedwiththe
docketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.
Forquestionsorinformationregardingthisguidance,contacttheOfficeofRegulatoryAffairs
(ORA),OfficeofPolicy,Compliance,andEnforcement(OPCE),FoodandDrugAdministration
atORAPolicyStaffs@.
U.S.DepartmentofHealthandHumanServices
FoodandDrugAdministration
OfficeofRegulatoryAffairs
OfficeofClinicalPolicy
CenterforBiologicsEvaluationandResearch
CenterforDrugEvaluationandResearch
CenterforDevicesandRadiologicalHealth
CenterforFoodSafetyandAppliedNutrition
CenterforTobaccoProducts
CenterforVeterinaryMedicine
June2024
ProcessesandPractices
Applicableto
BioresearchMonitoring
Inspections
GuidanceforIndustry
Additionalcopiesareavailablefrom:
OfficeofPolicy,Compliance,andEnforcement
OfficeofRegulatoryAffairs
FoodandDrugAdministration
12420ParklawnDrive,ElementBuilding,Roc
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