FDA Takes New Run at DMCs in Clinical Trials
By EsqSocial Corporation 16/04/24
Earlier this year, the US Food and Drug Administration (FDA) published new draft guidance substantially revising the agency’s previous guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs). Since the original guidance was published in 2006, the agency has noticed an uptick in not only DMC usage but also broader DMC functions. As DMC use has changed, the guidance provides detailed considerations for sponsors regarding a variety of areas, including when a...
By: Morgan Lewis - As Prescribed