FDA News

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She was instrumental in helping create the Baldrige Performance Excellence Program named after her brother
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UDI system could improve quality of information in medical device adverse-events reports
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Conference addressed how tools are being applied to mitigating risks and manage global supply chains
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Co-sponsored by ISPE and FDA, June 4–5, 2012, in Baltimore
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Public comment sought on three documents
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The $595 million collected will will help reduce average total review times, says FDA
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March 28–29, 2012, in Boston
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Includes full texts of every device-related regulation currently in force
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Dec. 13, 2011, from 10 a.m.–4 p.m. EST
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Reduce errors from unstable environments, increase repeatability and reproducibility
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Nov. 1–2, 2011, in Washington D.C.
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IRCA’s latest supports global supply-chain integrity
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Three educational tracks will be dedicated to manufacturing, laboratory, and IT best practices
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Registration suspensions and mandatory recalls are a couple of the new enforcement options for the FDA
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Agency continues to seek improvements to the device review process
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Guidance clarifies the kinds of changes that trigger the need for a new submission
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Web-based food-related emergency exercises help stakeholders gauge their response to potential disasters
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Aug. 9–11, 2011, in Bethesda, MD