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Investigation labeling of sterile topical

  • 1.  Investigation labeling of sterile topical

    Posted 10-Oct-2017 15:28

    My company is conducting a study (both US and ex-US sites) for a topical cream that after filling into tubes is terminally sterilized via gamma irradiation.  Does the term "sterile" need to be included on the investigational label?  This was mentioned but I can't find anything in the regs/guidances to support.

     

    Thank you

    Tom

    Chicago



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