User Fee Bill Puts Industry, U.S. FDA to Work On Global Supply Chain Risks
This article was originally published in PharmAsia News
The user fee legislation U.S. 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.
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Legislative language would consider a drug adulterated if it does not have the necessary quality management systems in place as required in current Good Manufacturing Practices.
FDA is continuing to draft a regulation for strengthening supply chain controls that he had announced in June 2010, Brian Hasselbalch of the agency’s center for drugs told a Parenteral Drug Association conference last month.
The broad outlines of the timing and scope of a U.S. legislative response to the global pharmaceutical supply chain crisis are taking shape