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11 April 2013
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The US Food and Drug Administration (FDA) is soliciting certain members of the biopharmaceutical industry to participate in a new pilot program that will help it determine whether its eSubmitter
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18 March 2013
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In a speech before the biotechnology industry of Massachusetts, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg explained that her agency is doing all that it can to meet the
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8 February 2013
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A new draft guidance document released by the US Food and Drug Administration's (FDA) drug and biologics research centers seeks to assist manufacturers and clinical investigators working on
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30 January 2013
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A famous quote from Shakespeare famously states that, "A rose by any other name would smell as sweet." But if a recent spat covered in The New York Times on the interchangeability of biological
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12 November 2012
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Health Canada has updated its current good manufacturing practices (CGMP) guidelines for Schedule D (biological) drugs and human blood and blood components.The updated guidance covers 13 distinct
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9 November 2012
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The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is about to become a little bit larger thanks to an agency merger that will see the creation of a new center aimed at better
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5 November 2012
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Vaccine manufacturers routinely have to deal with the difficulty of meeting science-based regulations. Such manufacturers operating in Indonesia may soon have another, and far more difficult, set of
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15 October 2012
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Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products
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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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8 October 2012
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A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement
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