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14 May 2013
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The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two
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13 May 2013
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The US Food and Drug Administration (FDA) may still be in the midst of figuring out how to overhaul its medical device compliance approach in regards to quality, but a new report out from device
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25 February 2013
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In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will
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25 February 2013
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EU regulators have released for public consultation a guideline under development by the International Conference on Harmonisation (ICH) intended to establish the best practices for controlling
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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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11 February 2013
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Canadian regulators have announced the suspension of all medical device licenses issued to or otherwise associated with one medical device manufacturer after being made aware of "concerns about the
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7 February 2013
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The International Conference on Harmonisation (ICH), the international pharmaceutical regulatory harmonization body, has released a draft guidance on the best practices for controlling carcinogenic
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5 February 2013
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Crises are rarely ones of regulators' own choosing. So in 2012 when pharmaceutical compounding became the topic de jure after a massive outbreak of fungal meningitis, state and federal regulators
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5 February 2013
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A new paper published in the journal Clinical Pharmacology & Therapeutics by two of the US Food and Drug Administration's (FDA) top drug regulatory officials argues that the market seems unable or
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Regulatory Update
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4 February 2013
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Brazil’s National Health Surveillance Agency (Anvisa) has issued a Guide to Quality Water Purification Systems for Pharmaceutical use which is directed to pharmaceutical manufacturers in Brazil. The
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