Ann: Ryoncil Commercial Launch Update and Product Pipeline, page-123

  1. 4,408 Posts.
    lightbulb Created with Sketch. 5736
    Interesting......

    According to FDA policy:

    "POLICY • FDA tentatively assigns an NDA classification code by the filing date for a new application and reassesses the code at the time of approval. The reassessment will be based upon relationships of the drug product being approved to products already "

    The codes are also updated daily..... so what could the hold up be?
 
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