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17 June 2013
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Once, professionals engaged in pharmaceutical regulatory affairs had only one agency to worry about: the US Food and Drug Administration (FDA), which has principal authority over whether a drug is
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12 June 2013
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A new piece of legislation introduced this week by Rep. Jim Gerlach (R-PA) would clarify that developers of orphan pharmaceutical products are exempted from an annual fee otherwise levied on
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5 June 2013
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US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the
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23 May 2013
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Three US legislators have moved to introduce legislation they say would accelerate US Food and Drug Administration (FDA) approvals while giving patients the option to obtain therapies outside of
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20 May 2013
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A prominent congressional Democrat this week announced the reintroduction of a bill that looks to ban the practice of so-called "gray market" drug sales, the practice of which has been partially
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17 May 2013
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Massachusetts U.S. Rep. Ed Markey has announced the reintroduction of legislation that he says is intended to open up clinical trial data, introducing a measure of transparency and bringing the US
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16 April 2013
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Top US regulatory officials may well be breathing a sigh of relief this week as at first legislators, and then finally the president, moved to pass a measure into law that would roll back new
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27 March 2013
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A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the
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21 March 2013
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US regulators fought back Thursday against allegations that the US Food and Drug Administration (FDA) is stifling the innovation of mobile medical applications and other mobile devices by developing
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7 March 2013
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A disaster and emergency preparedness bill that would task the US Food and Drug Administration (FDA) with setting up new regulatory incentives and accommodations for medical countermeasures has passed
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