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  • 1.  Orphan Drug

    Posted 25-Jul-2018 17:03
    Hi, 

    I am preparing Orphan Drug Submission for Biological product ( I am just in training )

    Can someone tell me which documents I need to submit?

    So far I have Cover Letter, Form 4035 and Medical document.

    Is there anything else it needs to be submitted?
    How do I make TOC of the whole submission?

    Thanks a lot,

    Masa

    ------------------------------
    Masa Razic
    Regulatory Affairs Specialist
    Boston MA
    United States
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  • 2.  RE: Orphan Drug

    Posted 26-Jul-2018 06:43
    Dear Masa,

    The information to be provided in a submission for Orphan Drug Designation can be found in 21 CFR 316.20.

    Data and information are usually included in a single document with appendices. One table of contents can be applied to the entire submission.

    You can find a summary of Orphan Drugs in my lecture here:https://hartmannwillner.com/resources/lectures/orphan-drugs-lecture/

    Sincerely yours, Suzanne

    ------------------------------
    Suzanne M. Sensabaugh, MS, MBA
    President and Principal Consultant
    HartmannWillner LLC
    100 M Street SE
    Suite 600
    Washington, DC 20003
    Phone: 202-749-8616

    www.hw-fda.com
    ------------------------------

    Original Message


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