E M Rodriguez
Affiliation: Food and Drug Administration
- The role of databases in drug postmarketing surveillanceE M Rodriguez
Division of Drug Risk Evaluation II, Office of Postmarketing Drug Risk Assessment, Center for Drug Evaluation and Research, FDA, 5600 Fishers Lane, HFD 440, Rockville, MD 20857, USA
Pharmacoepidemiol Drug Saf 10:407-10. 2001..Finally, we discuss the FDA's use of the databases it accesses through its Cooperative Agreement Program to conduct high priority studies to support regulatory decision-making...
- Postmarketing reports of QT prolongation and ventricular arrhythmia in association with cisapride and Food and Drug Administration regulatory actionsD K Wysowski
Office of Post-Marketing Drug Risk Assessment, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Am J Gastroenterol 96:1698-703. 2001....