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Concerning Issues Regarding Generic Approval

Posted 08-20-17 at 06:55 PM by wonderboy
Two profoundly concerning issues with respect to generic companies receiving approval for their product


1) What is even more interesting (and, in my opinion, both unacceptable and unethical) is the "testing process" which a generic company completes in order to complete the application (an ANDA) to the FDA, for ultimate approval. Here is what I mean:

1) The generic company --alone-- performs all the tests to ensure it is commensurate with the Brand...
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