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3 April 2013
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The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it
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12 March 2013
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Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance
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20 February 2013
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"The code is more what you'd call 'guidelines' than actual rules," quipped actor Geoffrey Rush in the 2003 blockbuster, "Pirates of the Caribbean," referring to an oft-broken and morally flexible
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25 January 2013
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A meeting proposed by US regulators would seek to bring together the US Food and Drug Administration (FDA), pharmaceutical trade industry group PhRMA, the regulatory science-focused Critical Path
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31 May 2012
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A Republican-led investigation into then-secret negotiations between the Obama Administration and the Pharmaceutical Research and Manufacturers of America (PhRMA) has released its preliminary results,
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23 May 2012
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The Food and Drug Administration Safety and Innovation Act (FDASIA) may have been deemed by Senate Majority Leader Harry Reid to be a “must pass bill,” but that hasn’t stopped a cavalcade of
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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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16 May 2012
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Republican members of the House Energy and Commerce (E&C) Committee announced in a 16 May statement they have obtained new information regarding the role of the White House in the 2009-10 negotiations
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10 May 2012
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The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012, a package of proposals to both fund and reform the agency, by a unanimous vote involving 46
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8 May 2012
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An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt
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