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  • 1.  Clinical Trials and claim substantiation

    Posted 15-Aug-2012 23:09
    Our company normally does some type of consumer testing, and they call it a "clinical trial" in order to establish product claims.

    However, the question has come up if we can do a clinical trial with an IRB, placebo, etc. to establish product claims, without it being a part of an NDA or IND, but part of an OTC drug claim substantiation such as "better than Brand X." I can only find information on clinical trials as part of NDA or INDs. Can anyone help me?

    Thanks,

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    Paula Bojsen
    Grand Rapids, MI
    United States
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  • 2.  RE:Clinical Trials and claim substantiation

    Posted 16-Aug-2012 16:12
    Paula:

    It is a great question.  Basically, your question relates to OTC and "Superiority Claim" as you state "better than Brand X."

    We've created a link to freely download the document to specifically answer your question here at OTC and Superiority Claim.  Click "1999 FTC Decision."  Upon entering your email address and click "Send," the said reference document will be automatically emailed to your email address you provided.  

    David

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    Regulatory Doctor and Coach
    www.GlobalComplianceSeminar.Com
    Riner VA
    United States
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