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FDA’s Electronic Record Review Enforcement Policies Present Challenges
Patrick Stone, President, TradeStone QA In 1999 the FDA released guidance for industry on the electronic records requirements for human clinical trials involving drugs, devices & biological...
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FDA’s CDER Unveils Ambitious 2015 Wish List
Michael Causey, Editor & Publisher, eDataIntegrityReport.com The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes...
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Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a key focus of the FDA. A revised FDA guidance offers new details and hones the scope previewing the agency’s pilot test of a risk-based system to track data submissions for...
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Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. Quality Management Efforts Will Be Impacted In 2017 In late December,...
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Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Quality management efforts could be impacted by what appears to be an aggressive guidance agenda for 2017 from the Center For Drug Evaluation and Research (CDER). Former FDA Chairman Robert Califf...
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