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zugelassen in Übereinstimmung mit den staatlichen Vorschriften der FDA
Explanation: You may want to refer to a report published in the German Language SIG of the ATA in June 1999. They explain the procedure to have drugs approved.
IF you cannot access this report,then please let me know. Perhaps I can mail a copy to you.
I have done tons of translations in the field of clinical trials.
This is a complex field; but basically the procedures are very straightforward.
Let me know.