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22 May 2012
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The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate’s iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving
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22 May 2012
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A group of 15 states is calling on the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA) to appeal a Judge’s decision in a lawsuit against both FDA and the states’ ability
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22 May 2012
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An advisory committee to the US Food and Drug Administration (FDA) gave US-based manufacturer Johnson & Johnson’s (J&J) blood thinner Xarelto (rixaroxaban), experimentally used to treat acute coronary
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21 May 2012
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The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency’s proposal to review
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21 May 2012
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The US Food and Drug Administration (FDA) announced in a Federal Register posting on 18 May it has not yet come to a conclusion regarding a Citizen Petition request to stop the issuance of national
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18 May 2012
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The US Food and Drug Administration (FDA) is planning an upcoming meeting to discuss the challenges of designing and implementing clinical trial designs for glucose sensors, as well as ways to improve
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18 May 2012
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The Government Accountability Office (GAO), the government agency in charge of auditing federal programs, has reviewed the US Food and Drug Administration’s (FDA) and found its employee performance
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18 May 2012
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The Federal Communication Commission’s (FCC) Chairman, Julius Genachowski, unveiled a plan to release new wireless spectrum to support the development of Medical Body Area Networks (MBANs), saying the
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18 May 2012
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The US Food and Drug Administration (FDA) announced it has approved eleven generic versions of Bristol-Myers Squibb and Sanofi’s blockbuster blood-thinner Plavix (clopidogrel bisulfate), marking the
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17 May 2012
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The US Department of Homeland Security (DHS) issued a warning on 4 May regarding the potential for medical devices to be compromised by hackers, saying “health care entities need to take [the threat]
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