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March 15, 2024 The U.S. Food and Drug Administration FDA today announced a comprehensive new webpage dedicated to showcasing how the agency employs its quality oversight tools, specifically inspections, in ensuring drug safety and quality across markets.
The FDA continuously monitors medications avlable on the market to guarantee they adhere to stringent safety and quality standards applicable to all drugs, regardless of their sourcewhether domestically or internationally manufactured.
We are committed to sharing pertinent information about our inspection activities for drugs in an accessible manner, sd Jacqueline Corrigan-Curay, Principal Deputy Center Director of CDER. By consolidating relevant data on a single public webpage, we m to enhance transparency and facilitate understanding of the FDA's role in ensuring drug quality alongside manufacturers.
The new webpage serves as a focal point for showcasing FDA's diligent oversight of pharmaceutical companies' adherence to current good manufacturing practice CGMP requirements. It provides an overview of the agency's efforts med at monitoring compliance with these stringent regulations. The page also delves into various regulatory instruments used by the FDA, such as warning letters and other corrective actions following CGMP inspections. Furthermore, it offers direct links to the FDA data dashboard page that highlights compliance-related actions.
To facilitate easy navigation through critical information on drug quality oversight activities conducted by the agency, this new webpage consolidates numerous resources in one place. The purpose is to increase transparency concerning how FDA carries out its duties and contributes to mntning drug safety and quality standards across multiple jurisdictions.
Content updated as of: March 15, 2024
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This article is reproduced from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-new-quality-oversight-webpage
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FDA Quality Oversight Webpage Drug Safety and Assurance Information Comprehensive Inspections for Medicines CGMP Requirements Compliance Highlighted Regulatory Instruments Overview by FDA Drug Quality Standards Maintenance Tools