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CDER Office of Compliance looks to secure drug, API supply chain

This article was originally published in The Gold Sheet

Executive Summary

The Office of Compliance in FDA's Center for Drug Evaluation and Research is considering contracting for help to get its planned Secure Supply Chain Pilot Program up and running. The program would provide incentives for drug manufacturers to develop secure routes for importing finished drugs and active pharmaceutical ingredients. The idea, FDA said in an Aug. 1 sources-sought notice, is to enable FDA field personnel to focus on the less secure supply routes in their efforts to prevent importation of diverted and counterfeit drugs. Other tasks for the contractor could include helping with preparing draft guidances on improving the safety, efficacy, quality and purity of imported drugs, and helping with Good Importer Practices policies, pandemic influenza preparedness and agreements with other countries

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