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  • 1.  Coming soon ads

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jul-2017 14:36
    This message was posted by a user wishing to remain anonymous

    ​​Hi,
    We have an agreement with a pharma company to buy their NDA once they receive FDA approval and my company will launch and market the product. We are not the NDA holder yet. Can we do Coming Soon" ads even though we are not the NDA holder?
    Thanks


  • 2.  RE: Coming soon ads

    Posted 20-Jul-2017 06:37
    No if it will not be a new active moiety and no if you will continue the same trademark to market.  The interesting question is if you used a new trademark like a generic.  I'm not sure if this is in the spirit of FDA's thinking for the coming soon regs, but I recall doing it I believe for the CFC-free version of QVAR (albuterol) metered does inhaler when I was general counsel of 3M Pharmaceuticals.  Make sure you know how to do it correctly. 

    Mark DuVal, JD, FRAPS
    DuVal & Associates, P.A.



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


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