Regulatory Open Forum

  • 1.  RE:Timing of Self-identification and GDUFA Fees

    Posted 23-Apr-2014 17:25
    Charles,
    Not sure I understood your question. Is the new generic drug you are preparing to manufacture an FDA approved drug for commercial distribution? If you answer is yes,  then you will need to identify as a generic manufacturer before you initiate manufacturing. Your client will have to add you to their NDA and you will also have to obtain FDA approval to manufacture drug products for commercial distribution.
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    Elvira Marquez
    San Diego CA
    United States
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