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Documents Regulatory Submission Datasets in the World of Evolving Standards Dave Christiansen, DrPH...

Slide 1Regulatory Submission Datasets in the World of Evolving Standards Dave Christiansen, DrPH Christiansen Consulting, CDISC Founding Director Safety and the Critical…

Documents What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.? Carole C....

Slide 1What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.? Carole C. Carey [email protected] Director, CDRH International Staff U.S.…

Documents United States Department of Agriculture Food Safety and Inspection Service Collaborative Efforts of....

Slide 1 Slide 2 United States Department of Agriculture Food Safety and Inspection Service Collaborative Efforts of Federal, State, and Local Public Health Partners in Foodborne…

Documents 1 FDA’s BIMO Inspection Program and IRB Inspections VA IRB Chairs Meeting August 2012 Janet...

Slide 11 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 the Commissioner…

Documents Randall Lutter, Ph.D. Deputy Commissioner for Policy U.S. Food and Drug Administration May 2009...

Slide 1 Randall Lutter, Ph.D. Deputy Commissioner for Policy U.S. Food and Drug Administration May 2009 Addressing Challenges of Economically-Motivated Adulteration Slide…

Documents FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug...

FDA Response to Foodborne Disease Outbreaks Elisa L. Elliot, Ph.D. Microbiologist U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of…

Documents 1 FDA Perspective on Nanomaterial- Containing Products Nakissa Sadrieh, Ph.D. Associate Director for...

FDA Perspective on Nanomaterial-Containing Products Nakissa Sadrieh, Ph.D. Associate Director for Research Policy and Implementation Office of Pharmaceutical Science, CDER,…

Documents 1 BIORESEARCH MONITORING AND IN VITRO DIAGNOSTICS SYBIL WELLSTOOD, PH.D. OFFICE OF COMPLIANCE...

BIORESEARCH MONITORING AND IN VITRO DIAGNOSTICS SYBIL WELLSTOOD, PH.D. OFFICE OF COMPLIANCE DIVISION OF BIORESEARCH MONITORING OBJECTIVES PROVIDE OVERVIEW OF THE CDRH BIORESEARCH…

Documents Research Needs to Support FDA Risk Communication Nancy M. Ostrove, Ph.D. Director for Risk...

Research Needs to Support FDA Risk Communication Nancy M. Ostrove, Ph.D. Director for Risk Communication May 1, 2009 Our Objective Help the public get the accurate, science-based…