FDA Considers Using Third-Party Inspectors to Enhance Global Reach
This article was originally published in The Gold Sheet
FDA is talking about adding an outsourced inspectorate to help it police the globally outsourced pharmaceutical manufacturing industry.
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The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.
The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape
The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape.