Novel Oral Anticoagulant Review Scorecard: Head-to-Head Study – Of FDA Divisions
Executive Summary
The recent wave of therapies intended to replace warfarin as the gold standard anticoagulant therapy has been an important medical and commercial story for the biopharma sector in the past five years. It also offers an unusual opportunity to compare the approaches taken to reviews by two different divisions within FDA’s Office of New Drugs.
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