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FDA Unveils Approach to Bioresearch Facility Inspections

Food and Drug Administration FDA releases draft guidance describing approach to inspection of bioresearch activities facilities subject to regulation

United statesDrug administrationPractices applicableBioresearch monitoring inspectionsDraft guidanceBioresearch monitoringRemote regulatoryStandard operating procedures

Processes and Practices Applicable to Bioresearch Monitoring Inspections

Processes and Practices Applicable to Bioresearch Monitoring Inspections; Draft Guidance for Industry

Radiological healthOffice of clinicalDrug administrationOffice of regulatory affairsGuidance issuing officeSubmit commentsClinical policyBiologics evaluationDrug evaluationFood safetyPractices applicableBioresearch monitoring inspectionsDrug omnibus reform act

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