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zipjet

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zipjet

Re: akasidney86 post# 107839

Tuesday, 11/02/2010 1:12:09 PM

Tuesday, November 02, 2010 1:12:09 PM

Post# of 257253
I am with you up to this:

I don't know from personal knowledge the answer to that question, but from what I've seen looking in from the outside, would doubt.



IF you mean, that you do not think FDA is going to tell an applicant that "yes you have established sameness" then I agree with that. It offers too much legal risk to go making pronouncements before the final decision. Clerks do not need that.

Did I get that right?

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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