Spring Intro 2023

03/03/2023

Take Home Message

 Know your drug!  Case by case is good science, not a “cop out”.

 Good Science is always better than blindly following guidelines  Know Regulatory guidelines and when to ignore them!   Address your Regulator’s needs   NEVER TRY TO HIDE BAD NEWS  Consider pre-submission meetings and scientific advice  Remember the 3 Cs - CLEAR, CONCISE, CRITICAL

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AVOIDS THE DELUSION THEY WANT TO LISTEN TO YOU!

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