Daniel DeCiero U.S. FDA

Daniel DeCiero is the Branch Chief of the Biological Drug and Device Compliance Branch in CBER’s Office of Compliance Biologics Quality (OCBQ), where he oversees reviews and evaluations of compliance and enforcement actions for biological products, drugs and devices regulated by CBER. He has been at the Agency since 2015 and was previously a Process and Facilities reviewer in CDER’s Office of Process and Facilities. In this role, he assessed proposed manufacturing and testing processes for filed drug applications (ANDA/NDA), including performing and assessing pre-approval inspections for related manufacturing facilities. Prior to joining FDA, he worked in systems engineering at General Dynamics and at Merck performing laboratory and pilot-plant scale development of APIs. He has a MS degree in Regulatory Science from the University of Maryland Baltimore and a BS degree in Chemical Engineering from Worcester Polytechnic Institute.