04. October 2015

    Recent confusion and ongoing actions related to theFDA’s Inactive Ingredient Database (IID) - What should beincluded in the ANDA?

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    Recent confusion and ongoing actions related to the FDA’s Inactive Ingredient Database (IID) - What should be included in the ANDA?
    David R. Schoneker
    Global Regulatory Affairs, Colorcon, Harleysville, PA
    988-5134-1-PB.pdf
    Adobe Acrobat Document 127.9 KB
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    Tags: excipient, fda, ingredient, inactive, database, IID, sep2015, maximum, daily, intake, MDI, IPEC-Americas