|
Drug Information Association
Annual Meeting - San Diego
June 2000
Assessing Quality of the Regulatory Review
Function
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
CERTs and the FDA Implementation of FDAMA 409,
Peter K Honig, MD, MPH (7/3/2000)
E-Environment at the FDA, Ralph Lillie,
Office of Information Technology (6/22/2000)
Electronic ICSRs: The US Pilot, Deborah
Yaplee, OPDRA (6/29/2000)
Expedited Development and Review Iniatives
- FDA Perspective
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
Integrating Pediatric Studies into Drug
Development Regulatory Perspectives, Victor Raczkowski (7/25/2000)
Patient Misuse and Investigator Fraud in
Clinical Trials: What Can Be Done? Part I, Stan W. Woollen, Deputy Director, Division
of Scientific Investigations, Center for Drug Evaluation and Research, FDA (6/27/2000)
Periodic Safety Updates: Opportunities and
Challenges - A U.S. Perspective, Peter K Honig, MD, MPH (7/3/2000)
Safety Reporting: FDAs Perspective,
Nancy Haggard, MPH (8/8/2000)
Update from the Office of Postmarketing Drug
Risk Assessment (7/3/2000)
Update on FACA and CDERs Advisory
Committees
Murray M. Lumpkin, M.D., Deputy Center Director, Center for Drug Evaluation and Research,
US Food and Drug Administration (6/22/2000)
Update on FDAs Pediatric Labeling
Regulations and Initiatives on Patient Drug Information, Victor Raczkowski (7/25/2000)
Whos in Charge Anyway? Responsibility
in Todays Clinical Trial Environment, Stan W. Woollen, Deputy Director, Division
of Scientific Investigations, Center for Drug Evaluation and Research, FDA (6/27/2000)
Back to Top Back to Presentations Page
FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DLIS
HTML by PKS |