Off-Label Pediatric Drug Use To Be Tracked Through FDA Database Contracts
Executive Summary
Off-label drug use in pediatric patients will be tracked under FDA contracts for longitudinal prescription data.
You may also be interested in...
FDA expands data mining contract
FDA is renewing a contract to allow the Office of Drug Safety to access San Diego-based Premier's database for inpatient drug utilization information. The agency is also awarding a contract that would allow the Division of Pediatric Drug Development to use Premier's pediatric inpatient data. The utilization data provides context for adverse event reports, modeling of drug risk based on usage patterns and calculating reporting rates for inpatient drug use, Premier said. FDA first contracted for access to Premier's inpatient data in 2001; the agency previously used the Child Health Corporation of America database for pediatric information (1"The Pink Sheet" Oct. 22, 2001, p. 9)...
FDA expands data mining contract
FDA is renewing a contract to allow the Office of Drug Safety to access San Diego-based Premier's database for inpatient drug utilization information. The agency is also awarding a contract that would allow the Division of Pediatric Drug Development to use Premier's pediatric inpatient data. The utilization data provides context for adverse event reports, modeling of drug risk based on usage patterns and calculating reporting rates for inpatient drug use, Premier said. FDA first contracted for access to Premier's inpatient data in 2001; the agency previously used the Child Health Corporation of America database for pediatric information (1"The Pink Sheet" Oct. 22, 2001, p. 9)...
FDA, Kaiser Discussing COX-2 Myocardial Infarction Study
FDA may use the Kaiser database to help assess the cardiovascular risk profile of COX-2 inhibitors