Foreign Regulatory Systems Can Be Strengthened By Receiving FDA Inspection Data, IOM Says
Institute of Medicine report recommends how FDA, industry and other stakeholders can strengthen food and drug regulatory systems abroad. It calls for FDA to provide incentives for foreign regulators to meet U.S. standards and facilitate training and for the government to help hold importers liable.
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Acting Deputy Commissioner John Taylor says training often is for reactive work, and FDA must shift to a more proactive strategy and ensure strong regulatory laws, equipment and organizations around the world.
Agency asks for stakeholder comments in advance of issuing a proposed rule on its new authority to detain potentially misbranded or adulterated drugs found during inspections, which was among FDASIA-mandated supply chain security improvements.
Agency meets with USAID stakeholders and wants to maximize the public health impact of its hand-held counterfeit drug detection device, which allows for quick preliminary screening of drug shipments to determine if counterfeit or adulterated product is present.