Using the FDA guidance Formal Meetings Between the FDA and Sponsors or Applican

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Using the FDA guidance Formal Meetings Between the FDA and Sponsors or Applican

Using the FDA guidance Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry, use the template for a Pre-NDA Meeting and prepare a Pre-NDA Meeting Request and Package. Make a detail letter and package intonation of drug Guselkumab (Tremfya).