Latest News
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25 April 2013
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The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical
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7 January 2013
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The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform
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Regulatory Update
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21 December 2012
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Health Canada will be requesting Development Safety Update Reports (DSURs) from selected sponsors of clinical trials for pharmaceuticals, biologics and biotechnology products, vaccines, and blood
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Regulatory Update
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1 October 2012
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Health Canada announced on 28 September the expansion of its pilot project on the use of drug review assessment information from foreign regulatory agencies, such as the European Medicines Agency, in
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21 June 2012
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Regular readers of the US Food and Drug Administration’s (FDA) weekly enforcement reports—the vehicle through which the agency publishes recalls initiated by or reported to FDA—will see a big change
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Latest News
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8 June 2012
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The US Food and Drug Administration’s (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency
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1 June 2012
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An item tucked within the US Food and Drug Administration’s (FDA) weekly enforcement report indicates the agency is looking to speed up the way it notifies the general public regarding pharmaceutical
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3 May 2012
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The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured
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Latest News
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5 March 2012
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The US Food and Drug Administration (FDA) announced 5 March that it is both closing the nominating process for its Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot
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