The report outlines OND’s efforts in 2023, including:  

• Over 3,400 formal meetings between sponsors of new drug development programs and CDER staff; 
• 25 public Advisory Committee meetings; 
• 55 novel drug approvals; 
• 34 guidances issued; 
• 651 OND speaking engagements; and 
•  OND representation at various meetings, including Critical Path Innovation meetings, Patient-Focused Drug Development meetings, and Patient Listening Sessions.  

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