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FDA's import-screening program sidelined by IT issues

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IT problems are being cited in the FDA delay of PREDICT, the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting initiative. The program is intended to help customs officers prevent adulterated and counterfeit drugs from entering the U.S.

Commissioner Margaret Hamburg unveiled PREDICT in early February. Implementation was expected this spring, reports SecuringPharma. The system uses barcode readers to access a central database in its objective of prioritizing imports for inspection using risk-based techniques, along the lines of those advocated by the regulator for use in drug manufacturing.

The project involves an initial roll-out in New York, following testing in Los Angeles.

- see the story

Related Articles:
FDA tool ranks imports by risk
Hamburg pushes toward "strong FDA"
USP to raise bar for drug transport


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