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Advanced Medical Isotope Corporation Message Board

  • kayak_wench kayak_wench Apr 26, 2014 6:03 PM Flag

    This could be relevant

    It at least shows that the FDA does not want to hinder the approval of devices that are improved over currently available devices.

    UPDATE 2-FDA proposes program to speed approval of medical devices
    Esha Dey and Susan Kelly
    Tuesday, 22 Apr 2014 | 4:06 PM ET

    April 22 (Reuters) - The U.S. Food and Drug Administration on Tuesday proposed speeding up medical device approvals for patients who have no other treatment options through a new program focused on earlier and more frequent interactions between companies and FDA staff.

    The Expedited Access Premarket Approval Application program is a response to criticisms by policymakers, patient groups and industry that the FDA process for approving medical devices is inefficient and slow, delaying patients' access to new, helpful products.

    The program is not a new pathway to market, the agency said, but rather a change in approach aimed at reducing the time it takes to develop a product and get it to market.

    It is similar to a new FDA program intended to expedite development of certain cancer drugs in the clinical trial stage, Morningstar analyst Debbie Wang said.

    "This is yet another aspect of how FDA is trying to work in a more coordinated fashion so they can reduce the number of false starts and situations of reinventing the wheel, and to help put some priority on which therapies are going to affect the most patients with the greatest need," Wang said.

    A device can be eligible for the program if it features breakthrough technology with significant benefits over existing products.

    In recent years, review times dragged out as the FDA faced a rising number of new product applications. Recent increases in the user fees paid by industry to fund FDA work could be providing more wiggle room for the agency to devote manpower to improving the application process, Wang said.

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