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The top documents tagged [research cber center]

A History of Stats at the FDA Mary A. Foulkes, Ph.D. U.S. Food And Drug Administration Office of Biostatistics and Epidemiology Center for Biologics Evaluation
A History of Stats at the FDA Mary A. Foulkes, Ph.D. U.S. Food And Drug Administration Office of Biostatistics and Epidemiology Center for Biologics Evaluation
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Foi and iig
Foi and iig
655 views
21 cfr part 11 guidance for industry
21 cfr part 11 guidance for industry
2.788 views
Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans
Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans
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1 GOOD MORNING! BONJOUR! GOEDEMORGEN!. 2 An Introduction to certain aspects of the US FDA Murray M. Lumpkin, MD Deputy Commissioner International Programs
1 GOOD MORNING! BONJOUR! GOEDEMORGEN!. 2 An Introduction to certain aspects of the US FDA Murray M. Lumpkin, MD Deputy Commissioner International Programs
217 views
Investigator-held IND Studies Jeffrey W. Clark, MD DF/HCC Medical Director for Clinical Trials Operations April 25, 2008
Investigator-held IND Studies Jeffrey W. Clark, MD DF/HCC Medical Director for Clinical Trials Operations April 25, 2008
216 views
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Roger D
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Roger D
213 views
FDA Considerations For Regulation Of Nanomaterial Containing Products Nakissa Sadrieh, Ph.D. Office of Pharmaceutical Science, CDER, FDA
FDA Considerations For Regulation Of Nanomaterial Containing Products Nakissa Sadrieh, Ph.D. Office of Pharmaceutical Science, CDER, FDA
218 views
FDA Regulatory Perspective: Data Integrity Steve Wilson, Dr.P.H., CAPT USPHS Deputy Director, Division of Biometrics II, CDER/FDA NIH Roadmap Program Feasibility
FDA Regulatory Perspective: Data Integrity Steve Wilson, Dr.P.H., CAPT USPHS Deputy Director, Division of Biometrics II, CDER/FDA NIH Roadmap Program Feasibility
222 views
FDA Regulatory Perspective: Data Integrity
FDA Regulatory Perspective: Data Integrity
172 views
An Interagency Model for Collaboration and Operation
An Interagency Model for Collaboration and Operation
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An Interagency Model for Collaboration and Operation Interagency Portal for Science Education Meeting National Academies of Science March 18, 2009 Sharon
An Interagency Model for Collaboration and Operation Interagency Portal for Science Education Meeting National Academies of Science March 18, 2009 Sharon
217 views