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16 April 2013
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Arguing that the issue of the safety of compounded pharmaceutical products is now at a "critical point," US Food and Drug Administration (FDA) Commissioner Margaret Hamburg plans to tell legislators
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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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25 March 2013
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Since the 1990s, the US Food and Drug Administration (FDA) has leveraged industry-paid user fees for an increasing number of product areas, starting with prescription drugs and branching off into
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21 March 2013
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The US Senate has approved a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees
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8 March 2013
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The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA), a law
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5 March 2013
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Legislators have introduced a piece of legislation in the US House of Representatives that would allow the US Food and Drug Administration (FDA) to spend user fees that it had previously been able to
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1 March 2013
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Congress has begun the process of taking up two bills that stand to make reforms to the user fee process for innovative and generic veterinary pharmaceutical products with the stated goals of
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15 February 2013
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US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration
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16 January 2013
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The US Food and Drug Administration (FDA) has published the user fee rates for facilities that manufacture active pharmaceutical ingredients (APIs) and finished dosage forms (FDF) for the current
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16 January 2013
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Federal regulatory agencies may have breathed a collective sigh of relief on 2 January 2013, when it was clear that US legislators had struck a last-minute deal to avert the so-called "fiscal cliff"
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