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Food and Drug Administration FDA releases draft guidance describing approach to inspection of bioresearch activities facilities subject to regulation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

FDA Warns Industry Of Fraudulent Unreliable Lab Testing Data In Premarket Submissions

FDA Warns Industry Of Fraudulent Unreliable Lab Testing Data In Premarket Submissions
meddeviceonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from meddeviceonline.com Daily Mail and Mail on Sunday newspapers.

Erikal robertsBioresearch monitoring programParty dataUnreliable laboratory testing data in premarket submissionsLab servicesGood laboratory practicesDivision of industryUnreliable laboratory testing dataPremarket submissionsMedical device manufacturersScrutinize third party generated dataMade in chinaAccreditation schemeConformity assessmentGood manufacturing practicesQuality management

GAO: FDA should audit hiring efforts to boost worker retention

GAO: FDA should audit hiring efforts to boost worker retention
fiercebiotech.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercebiotech.com Daily Mail and Mail on Sunday newspapers.

Government accountability officeUs department of healthHuman servicesBioresearch monitoring

FDA clinical inspections are plummeting due to staffing issues

Employees are also concerned some of their inspection findings are being ignored.

United statesHuman services departmentDrug administrationGovernment accountability officeBioresearch monitoring

FDA s Center for Drug Evaluation and Research (CDER) Issues FY2023 Annual Report | Gardner Law

In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces.

Office of complianceDrug evaluation researchAnnual reportClinical trial oversightBioresearch monitoringDrug compounding complianceAssessing drug supply chain risksDrug manufacturingTrial oversightInstitutional review boardDrug supply chain security actCurrent good manufacturing practiceQuality control unitRecord review