The link below is a list of Dr. Timothy Coté referenced publications.
PUBLICATIONS
About Coté Orphan, LLC
Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. Coté Orphan knows the FDA hurdles unique to orphan products and forges successful pathways to orphan product designation. For more information on Coté Orphan, please call or visit coteorphan.com.
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