U.S. Legislative Response to Heparin Crisis Begins to Take Shape
This article was originally published in The Gold Sheet
Executive SummaryThe broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape.
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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.