Latest News
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13 December 2012
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Patient groups, regulatory agencies and companies are increasingly finding use in the establishment of patient registries—databases of patient data usually specific to a particular disease, and often
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Latest News
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21 September 2012
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The US Food and Drug Administration (FDA) is planning a meeting to discuss the agency's patent-focused drug development initiative, an attempt to identify neglected or under-served diseases with an
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Latest News
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13 June 2012
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The US Food and Drug Administration (FDA) has released new guidance detailing how sponsors should include additional warnings on their products to reduce the risk of the transmission of
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12 April 2012
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International healthcare bodies are looking to issue guidelines on ‘dual use’ research on potentially hazardous materials and diseases after a researcher sent shockwaves through the medical community
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Regulatory Update
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5 April 2012
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Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers
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Latest News
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22 March 2012
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A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools—specifically the micro-blogging website Twitter—to provide the agency with advanced signals to
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16 March 2012
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Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the
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