is being presented by Kyle Sampson, Partner, with Hunton & Williams LLP and airs on Thursday, November 3rd, 2011. For more details, or to register please visit our site at www.fxconferences.com
The FDA may detain and ultimately refuse the admission of food, drugs, devices and cosmetics offered for import if the products “appear” to violate regulatory requirements. FDA also may subject products, manufacturers, and countries to “detention without physical examination.” These FDA authorities are significant, as 40% of the drugs Americans take are manufactured outside the U.S., and 80% of active pharmaceutical ingredients come from non-U.S. sources. In 2011, more than 24 million shipments of FDA regulated products will be offered for import.
In recent years, lawmakers have pressed FDA to monitor imports more closely, driven by incidents of fatal drug contamination – like the 2008 incident involving the blood thinner Heparin. In response, FDA has launched new enforcement initiatives and increased the number of import holds, detentions and refusals. So how can importers adjust to this new reality? And what should they do if they run afoul of FDA? This audio conference presentation explains FDA’s powers in this area, recommends steps to avoid import problems, and describes how to fight holds, detentions and refusals.
