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25 February 2013
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The European Medicines Agency (EMA) has announced that application fees will go up approximately 2.6% in the coming fiscal year, roughly on par with the EU rate of inflation for the previous year.The
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13 September 2012
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The European Medicines Agency (EMA) has released a revised set of rules regarding the fees payable to the agency for the submission of medicinal products and the maintenance of regulatory
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30 July 2012
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The schedule of fees medical device manufacturers and sponsors will be required to pay under the Medical Device User Fee Act (MDUFA)—part of the recently passed Food and Drug Administration Safety and
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4 April 2012
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Health Canada released a bevy of guidance documents updating the fee structures for pharmaceutical products and medical devices.“Health Canada would like to inform sponsors that the following
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30 March 2012
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The European Medicines Agency (EMA) is preparing to raise fees by 3.1% on 1 April 2012 for all applicants and marketing-authorization holders (MAHs), the agency said in a statement.“Every year, the
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13 March 2012
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The US Drug Enforcement Administration (DEA), a division of the US Department of Justice (DOJ), released an updated adjustment of the registration and reregistration fees associated with its Diversion
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1 February 2012
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Several news organizations are reporting that parties are close to a deal in the negotiations over the Medical Device User Fee Act (MDUFA). The agreement between the US Food and Drug Administration
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