• Regulatory NewsRegulatory News

    EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses

    With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer. EMA EMA’s Pharmacokinetic Working Party (PKWP) and the Modelling and Simulation Working Group (MSWG) are developing a “ Guideline on the Qualification and Reporting of Physiologi...
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    FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses

    • 01 December 2016
    The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format. PBPK Analyses According to FDA, "PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to mechanistically describe the [pharmacokinetic] PK and/or pharmacodynamic (PD) behaviors of a drug." These analyses, FDA sa...
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    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
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    FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

    The US Food and Drug Administration (FDA) has sent untitled letters to two companies selling a medical product that is intended for training purposes only. The letters were sent more than eight months after recalling the product, which was linked to two deaths. FDA said its investigation of adverse events associated with the use of Wallcur’s “Practi-0.9% Sodium Chloride” product identified several ways in which Florida-based PSS World Medical and Connecticut-based Moore ...