Latest News
Regulatory Update
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20 November 2012
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Japan’s Pharmaceutical and Medical Device Agency (PMDA) has launched J-MACS (Japanese Registry for Mechanically Assisted Circulatory Support), a data-collection project on the post-marketing
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Regulatory Update
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15 October 2012
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Japan’s Pharmaceutical and Medical Device Agency (PMDA) has reorganized its Offices of Biologics I and Biologics II, respectively, into new entities known as the Office of Cellular and Tissue-based
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Latest News
Regulatory Update
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7 September 2012
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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has issued a newly-updated Q&A document that revises its 2007 guidance on conducting international clinical trials. PMDA recommends that
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Regulatory Update
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10 May 2012
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Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is announcing the publication of an English translation of a guidance document detailing how first-in-human studies are to be conducted.The
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Latest News
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23 April 2012
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The Korean Food and Drug Administration (KFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) have applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the
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