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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.
Investigator-held IND Studies Jeffrey W. Clark, MD DF/HCC Medical Director for Clinical Trials Operations April 25, 2008.
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Roger D.
FDA Considerations For Regulation Of Nanomaterial Containing Products Nakissa Sadrieh, Ph.D. Office of Pharmaceutical Science, CDER, FDA.
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
© 2011 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED. Challenges in Clinical Research Trials Christee G. Laster Smith Moore Leatherwood LLP 1180 W.
Toxicology in Drug Development Lynnda Reid, Ph.D. Pharmacology/Toxicology Reviewer Center for Drug Evaluation and Research (CDER) Rafael Ponce, Ph.D.,
