• Health Canada Announces Fee Changes For Drugs, Devices

    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 documents have been revised to reflect fees that are current as of 1 April 2012," the agency said in a statement. The fees for devices and pharmaceutical products reflect a 2% increase "as well as other minor revisions to improve clarity" of various guidance documents. The agency...
  • EMA Application, MAH Fees Set to Rise 3.1% on 1 April

    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 Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year," said EMA in a statement posted on its website. "All applications received at the Agency by 31 March 2012 will be charged at the current fee and reduction rates. App...
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    Demystifying the RAPS Fellows Application and Selection Process

    History was made when the inaugural class of RAPS Fellows was honored at the 2008 RAPS Annual Conference in Boston. I was fortunate to have been selected as a member of that class. I have served as a member of the RAPS Fellows Selection Committee every year since, and currently serve as the vice chair. Many colleagues have inquired about how they can become Fellows, but they end up not completing an application. The reasons are varied-too busy, lack of knowledge of the q...
  • NICE Launching Mobile App For Accessing All Recommendations

    The UK's National Institute for Health and Clinical Excellent (NICE), the National Health Service's (NHS) rationing body, is releasing a new mobile application that provides access to all of NICE's recommendations and advice. The app contains more than 760 pieces of NICE guidance, reports the agency, and is automatically updated when new guidance is released. "The app will provide offline access to all of NICE's guidance products, including clinical guidelines, public...
  • Shire Pulls BLA Submission After FDA Demands More Clinical Trials

    • 16 March 2012
    Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the company needed to conduct more clinical trials. Ireland-based Shire's withdrawal of its application on 15 March was reportedly due to the perception that FDA's demands would create a "significant delay" that would push back any possible approval of the product by years. FDA has ...
  • FDA Proposes New Regulations for Unapproved Animal Drug Residues in Imported Food

    The US Food and Drug Administration (FDA) released a new proposed regulation on Wednesday, 25 January that aims to provide a stable pathway for persons requesting the import of food items containing residues of animal drugs that are unapproved in the US. The proposed regulation -  Import Tolerances for Residues of Unapproved New Animal Drugs in Food   - is the final outstanding action FDA needs to take to fully implement the Animal Drug Availability Act of 1...