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Re: ThomasS post# 113230

Tuesday, 01/25/2011 5:44:50 PM

Tuesday, January 25, 2011 5:44:50 PM

Post# of 257272
Tom,

I cannot confirm either quote. But the two statements are not inconsistent if properly understood.

On non-approvable vs deficiency letters: It is my understanding that the language used by FDA has changed.

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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