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FDA launches secure supply chain pilot program

This article was originally published in The Gold Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research announced that it will select up to 100 applicants to participate in a voluntary pilot program that is aimed to promote the safety of drugs and active drug ingredients produced outside the U.S. The program would provide incentives for drug manufacturers to develop secure routes for importing finished drugs and active pharmaceutical ingredients. To qualify, applicants will need to demonstrate that they maintain control over their drug products from the time of manufacture through entry into the country. There will be a limit of five drug products per applicant. In order to participate, an applicant must be an NDA or an ANDA holder or the foreign manufacturer of an imported finished drug product
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