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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Food and Drug Administration FDA releases draft guidance describing approach to inspection of bioresearch activities facilities subject to regulation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-states
Drug-administration
Practices-applicable
Bioresearch-monitoring-inspections
Draft-guidance
Bioresearch-monitoring
Remote-regulatory
Standard-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.

India
China
Erikal-roberts
Alcoa
Deloitte
Bioresearch-monitoring-program
Party-data
Unreliable-laboratory-testing-data-in-premarket-submissions
Lab-services
Good-laboratory-practices
Division-of-industry

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-office
Us-department-of-health
Human-services
Bioresearch-monitoring

FDA clinical inspections are plummeting due to staffing issues

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

United-states
Americans
Human-services-department
Drug-administration
Government-accountability-office
Bioresearch-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-compliance
Drug-evaluation-research
Annual-report
Clinical-trial-oversight
Bioresearch-monitoring
Drug-compounding-compliance
Assessing-drug-supply-chain-risks
Drug-manufacturing
Trial-oversight
Institutional-review-board
Drug-supply-chain-security-act

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