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Gregory Glass

FDA Petitions

Gregory Glass
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gregoryglass

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@gregoryglass

active 2 days, 10 hours ago
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    Product: Ketorolac Tromethamine Tablets
    Company: Teva, Mylan, various
    Petition Filer: Fox Rothschild, a law firm
    Petition Number(s): 2020P-0745
    Date of Petition: February 12, 2020
    Responding Petitions:

    Issue and Implication: Whether FDA must designate a second Reference Standard.

    Action Requested by Petitioner: Petitioner is…[Read more]

    Profile picture of gregoryglass 4 days, 14 hours ago

    Product: Erectile Dysfunction Drugs (Cialis® (tadalafil), Levitra® (vardenafil), Viagra®(sildenafil))
    Company: Eli Lilly, Bayer, Pfizer and various
    Petition Filer: Physicians for Responsible Medicine
    Petition Number(s): 2020P-0698
    Date of Petition: February 10, 2020
    Responding Petitions:

    Issue and Implication: Whether the class la…[Read more]

    Profile picture of gregoryglass 6 days, 11 hours ago

    Product: Dextrose in Plastic Containers
    Company: Baxter Pharmaceuticals
    Petition Filer: Fresenius Kabi
    Petition Number(s): 2020P-0678
    Date of Petition: February 7, 2020
    Responding Petitions:

    Action Requested by Petitioner: The petitioner would like to FDA to determine whether Dextrose, 70gm/100mL (NDA 017521) was removed for…[Read more]

    Profile picture of gregoryglass 1 week ago
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