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8 April 2013
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The US Food and Drug Administration (FDA) has announced that it will begin to solicit comments from industry and the public regarding a pending regulation that would expand its authority to
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Regulatory Update
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8 April 2013
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Brazil’s National Health Surveillance Agency, Anvisa, has released a pharmaceutical production cleaning validation guide which, according to the agency, is based on international guidelines. The
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8 April 2013
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US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both
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5 April 2013
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Americans don't particularly trust the pharmaceutical industry. But the extent to which that trust deficit exists is on particularly glaring display in a new survey, which shows that more than one in
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Regulatory Update
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29 March 2013
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India’s Drugs Controller General (DGC), in an order dated 26 March 2013, has convened a special committee to investigate allegations that the Central Drugs Standard Control Organization (CDSCO) did
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28 March 2013
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Regulatory science may be one of the biggest trends in US and EU regulatory circles, but now that fervor is making its way to a new corner of the globe: Taiwan.In a statement, Taiwan's National Cheng
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28 March 2013
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The Korean Food and Drug Administration (KFDA) is no more, the agency said in an announcement on 28 March 2013. Instead, it—like its Chinese counterpart, the China Food and Drug Administration (CFDA),
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Regulatory Update
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25 March 2013
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Brazil’s National Health Surveillance Agency (Anvisa) has announced the adoption of a set of measures intended to modernize and expedite the marketing approval review process for new products subject
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20 March 2013
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Just one week after the US Food and Drug Administration's (FDA) Director of the Office of Generic Drugs (OGD), Greg Geba, announced he would step down from his position, agency officials have
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15 March 2013
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A safety warning released on 14 March 2013 by the US Food and Drug Administration (FDA) states that regulators have become aware of and are investigating reports that incretin mimetic drugs for type-2
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