Published in Medical Letter on the CDC and FDA, November 28th, 2004
LAB said that successful pre-IND meetings with both U.S. and European regulatory bodies resulted in a development program applicable for both territories, thus enabling expedient further development of the product.
According to the announcement, the Phase II trial will be a multi-center trial in several European countries. The primary objective is to demonstrate the clinical efficacy of Fentanyl Taifun in patients with...
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