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Latest News | 25 February 2013

European Marketing Application Rates Set to Increase in 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 Read More...


Latest News | 13 September 2012

EMA Updates Its Fee Structure Guidance

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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 Read More...


Latest News | 30 July 2012

Upcoming Medical Device User Fees Unveiled

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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 Read More...


Latest News | 4 April 2012

Health Canada Announces Fee Changes For Drugs, Devices

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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 Read More...


Latest News | 30 March 2012

EMA Application, MAH Fees Set to Rise 3.1% on 1 April

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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 Read More...


Latest News | 13 March 2012

US DEA Releases Fee Schedule for Chemical Registrations

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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 Read More...


Latest News | 1 February 2012

UPDATED: Industry Stakeholders, FDA "Agree in Principle" to Double MDUFA Fees

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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 Read More...


RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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