TSN 0.00% 1.0¢ the sustainable nutrition group ltd

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  1. TDA
    11,411 Posts.
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    Jeez we're lucky aren't we, thanks for that link GKM:

    FDA Pins ANDA Backlog on Inspection Resources, Calls for User Fees
    The FDA is telling generic-drug makers that a lack of resources to conduct inspections outside of the U.S. is largely to blame for the agency?s backlog in ANDAs and is urging the industry to accept user fees as a solution the problem. In a speech Thursday at the Generic Pharmaceutical Association annual meeting in Orlando, Deborah Autor, director of the FDA?s Office of Compliance, told drugmakers that the agency currently has 192 foreign generic-drug manufacturing facilities requiring a pre-approval inspection but, because of its limited resources, is only scheduled to conduct 62 of those inspections in fiscal 2011.


 
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