US FDA Commissioner launches PREDICT ' a new system for assessing imported drugs risks

US Food and Drug Administration Commissioner Margaret Hamburg last week announced the launch of a new risk-assessment tool to ensure the safety of imported drugs and food. The web-based PREDICT (the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting ) system will rank the risk hazards of food and drugs as they enter the country and allow inspectors to focus on the most likely threats to public health.

FDA's new PREDICT risk-based screening system for imports will replace the admissibility screening function of OASIS, the FDA's legacy system. PREDICT will assist entry reviewers in targeting higher-risk shipments for examination. It will also expedite the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers.

Launching the project before a meeting at the Center for Strategic and International Studies, Commissioner Hamburg noted that up to 40% of the drugs Americans take are imported, and up to 80% of the active pharmaceutical ingredients in those drugs come from foreign sources. So we are definitely talking about real numbers.