Regulatory Open Forum

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  • 1.  Generic drug submission to FDA (not a full ANDA)

    Posted 25-Mar-2022 12:45
    I am looking for a regulatory consultant available for working with us next week relating to a question of submission of a communication to FDA relating to development of a generic drug product (this is not for a full ANDA).  Experienced consultants with availability and reasonable rates please send me a note at len@transformative.legal.  Thank you.

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    Len Smith
    Counsel (Patents/IP/Contract/Regulatory)
    Scottsdale AZ
    United States
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  • 2.  RE: Generic drug submission to FDA (not a full ANDA)

    Posted 26-Mar-2022 09:02

    I am just joking but I am not sure these: "Experienced consultants with availability and reasonable rates" can be reasonable expected to be all true simultaneously...



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    Sorin Alb RAC
    Project Manager, Regulatory Affairs
    Scarborough ON
    Canada
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  • 3.  RE: Generic drug submission to FDA (not a full ANDA)

    Posted 26-Mar-2022 21:33

    LOL - but, you know, you raise a good point Sorin.  It's well said that you can't ask to win on price, quality, and speed all at once, so I withdraw my "reasonable rates" statement as I am seeking expertise on dietary supplement labeling urgently, so I will happily pay premium rates for the help I am seeking.

    Thanks for the laugh (at myself) and the opportunity to revise my request to the community.  Hope you all are having a nice weekend.



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    Len Smith
    Counsel (Patents/IP/Contract/Regulatory)
    Scottsdale AZ
    United States
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