PREDICT Shows Promise Despite FDA IT Integration Delays: GAO

The FDA’s recently deployed computer system that ranks imports according to risk was praised in a new government report, but a former agency official says it’s essentially stuck in neutral, citing the report’s chiding remarks about FDA sluggishness in integrating its legacy IT systems. The slow-walked effort is limiting the agency’s regulatory effectiveness and ability to handle information associated with the rising flood of drug and device imports, the Government Accountability Office (GAO) report states. Compounding matters is the FDA’s lack of a comprehensive list of existing and planned IT systems, the GAO report adds.
International Medical Device Regulatory Monitor