Tag Archive: IRB

Sep 19 2013

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on risk-based monitoring, which is being pushed both by FDA and industry. Select Updates for Non-Clinical …

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Dec 06 2012

FDA’s New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Dec 06 2012

FDA's New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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