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15 May 2013
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US regulators on Tuesday announced the approval of the US' first companion diagnostic test to detect a gene mutation associated with a type of lung cancer, giving lung cancer patients a similar
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15 May 2013
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The US Food and Drug Administration (FDA) has finalized labeling changes for zolpidem-containing products, the main ingredient in the sleep-aid drugs Ambien CR and Edluar, after issuing a warning
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15 May 2013
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French regulator ANSM has announced yet another problem—the second in as many weeks following a major scandal in 2012—this time with the Jarvik 2000 heart device due to violations of French laws and
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15 May 2013
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The US Food and Drug Administration (FDA) sends warning letters to companies for many reasons, running the gamut of deficient manufacturing practices, false advertising, unapproved products and a
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15 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US Fraud Cases' Impact on Ranbaxy May Climb as High as $1 Billion (India Times) Confusion
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14 May 2013
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US regulators of medical devices, and indeed all regulators, must balance two competing needs when it comes to regulation: the desire for a process to be as simple as possible, and the desire for a
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14 May 2013
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The National Association of Attorneys General, an organization comprised of all state attorneys general, has sent a letter to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking
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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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14 May 2013
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Republican legislators on the House Energy and Commerce Committee announced on 13 May 2013 that they are opening an investigation into the unusual and unexpected departure of one of the US Food and
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14 May 2013
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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US US Government Files Morning-After Pill Appeal (AP) (WSJ) (CBS) (The Hill) (SCOTUS Blog)
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