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Re: mouton29 post# 101624

Sunday, 08/15/2010 2:50:56 PM

Sunday, August 15, 2010 2:50:56 PM

Post# of 257262

though I don't think it is as clear cut as I had after I had only read the briefs from one side.



I agree.

It seems to me that the prohibition against requiring testing is intended to benefit the applicant (who cannot be required to provide study data) and NOT to promote monopoly pricing of the branded. If in that situation if the court were to find that there was a violation by the FDA, the purpose of the statute would not be promoted by forcing the generic off the market. Quite the opposite.


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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