Regulatory Submission Datasets in the World of Evolving Standards Dave Christiansen, DrPH Christiansen Consulting, CDISC Founding Director Safety and the.
What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.? Carole C. Carey [email protected] Director, CDRH International.
United States Department of Agriculture Food Safety and Inspection Service Collaborative Efforts of Federal, State, and Local Public Health Partners in.
1 FDA’s BIMO Inspection Program and IRB Inspections VA IRB Chairs Meeting August 2012 Janet Donnelly RAC, CIP Office of Good Clinical Practice Office of.
Randall Lutter, Ph.D. Deputy Commissioner for Policy U.S. Food and Drug Administration May 2009 Addressing Challenges of Economically-Motivated Adulteration.
FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied.
1 FDA Perspective on Nanomaterial- Containing Products Nakissa Sadrieh, Ph.D. Associate Director for Research Policy and Implementation Office of Pharmaceutical.
1 BIORESEARCH MONITORING AND IN VITRO DIAGNOSTICS SYBIL WELLSTOOD, PH.D. OFFICE OF COMPLIANCE DIVISION OF BIORESEARCH MONITORING.
Research Needs to Support FDA Risk Communication Nancy M. Ostrove, Ph.D. Director for Risk Communication May 1, 2009.
