Tag: FDA

New European Clinical Trials Register Website

18 Mar 2016
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Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

30 Mar 2015
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FDA definition of Raw data

03 Mar 2015
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FDA Warning Letters

03 Feb 2015
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Medical Device Classes according to the FDA

21 Feb 2014
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Key differences between 510 K and PMA

21 Feb 2014
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FDA and IMB (HPRA) product recall examples

13 Nov 2013
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Eudralex and FDA Complaints and Product Recall Guides

11 Nov 2013
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What is a Qualified Person?

25 Oct 2013
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The Orange Guide and the Orange Book

23 Oct 2013
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Example of FDA warning letter

25 Sep 2013
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