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27 February 2013
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A new draft guidance published by the US Food and Drug Administration (FDA) recommends revised screening procedures to guard against the threat of syphilis contamination in donated blood and plasma,
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19 February 2013
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What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon
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4 February 2013
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The US Food and Drug Administration (FDA) has released a draft guidance pertaining to a document currently under development by the International Conference on Harmonisation (ICH) that would harmonize
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5 December 2012
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Canadian regulators are scrambling to re-evaluate more than 20 companies' approved and pending products after finding "falsified" testing results during the course of an inspection at Ontario-based
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14 November 2012
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The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it
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10 October 2012
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The National Toxicology Program (NTP) has announced a new classification criterion that it says should require between 50% and 83% fewer animals to be used during testing to determine whether a
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Regulatory Update
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6 September 2012
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China’s State Food and Drug Administration (SFDA) has issued guidance to provincial and municipal food and drug agencies and the Chinese Institute of Food and Drug Testing concerning the
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29 August 2012
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The U.S. Food and Drug Administration (FDA) is changing the rules for human blood testing and storage, according to a report by in-Pharma Technologist.A new procedure issued by FDA allows for
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24 July 2012
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A new project funded by the National Institutes of Health (NIH) could assist regulators by allowing the US Food and Drug Administration (FDA) to develop test chips to evaluate the toxicity of novel
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28 June 2012
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A Presidential Commission in charge of studying bioethics wants to know: what are the ethical issues associated with studying medical countermeasures in children?In a 28 June Federal Register posting,
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