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23 April 2013
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Patients are, as regulators and industry frequently remind each other, at the heart of every regulatory process and decision. But it can sometimes be difficult to find patients in the regulatory
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29 January 2013
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The last decade has seen an increasing shift into digital forms of communication, submission and information in the regulatory affairs space. Sponsors can now submit applications and submit updates to
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28 November 2012
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So long, Global Harmonization Task Force (GHTF). The global medical device harmonization body has finally disbanded, leaving its unfinished work to the International Medical Device Regulators Forum
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26 June 2012
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Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a
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25 June 2012
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[Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not
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31 May 2012
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South Korea’s Korean Food and Drug Administration (KFDA) has announced the re-launch of its website, which now includes consolidated drug information covering all drugs manufactured in South Korea.The
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31 May 2012
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The European Medicines Agency (EMA) is looking to enhance its transparency measures surrounding the receipt and publication of adverse event reports for all medicines authorized in the European
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25 May 2012
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A recent memo from the White House to the heads of executive departments and agencies directs them to immediately begin implementation of a new “digital strategy” aimed at making governmental
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9 May 2012
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The European Medicines Agency (EMA) has announced it has rolled out several usability upgrades for its website, allowing regulatory professionals to access a host of new and customizable features that
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30 April 2012
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The European Medicines Agency (EMA) is announcing a planned closure of its office on 1 May and website maintenance to occur between 2-3 May.EMA’s office will close on 30 April at 6:30 PM GMT and
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