FDA's proposed solution is being dubbed "The Case for Quality"—a tripartite approach consisting of a focus on quality, enhanced transparency and stakeholder engagement.
FDA Looking to Overhaul Compliance Approach > RAPS > News - Article View:
"The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies."
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Wednesday, August 15, 2012
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