US Pharm. 2008;33(5):69.

FDA Releases Stent Recommendations
The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries. Each year in the U.S., approximately one million patients undergo procedures to treat coronary atherosclerosis, and some 650,000 of them are treated with drug-eluting stents. Concerned about clot formation in some patients years after implantation, the agency has monitored the devices closely over the past several years.

Three coronary drug-eluting stents are currently FDA-approved. The guidance document also assesses the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. These stents combine device and drug technology and, as such, the document contains expertise and input from two agency centers--the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research.

Agents Seize Illegal Dietary Supplements
United States marshals seized more than $1.3 million worth of dietary supplements from LG Sciences, LLC, of Brighton, Michigan, because the products contain unapproved food additives and/or new dietary ingredients. The seized supplements, which are marketed for use by body builders, were marketed under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.

"I commend the professionalism and swift action of the FDA investigators who discovered and investigated this serious problem, and I am glad our lawyers could provide the legal muscle needed to support the seizure," said U.S. Attorney Stephen J. Murphy.

Because the FDA has not received scientific information on the safety of the seized supplements, the agency recommends that consumers who have the products discuss their use with their health care professionals. The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products' use.

Progress on New China Office
The FDA has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending approval from the Chinese government. The agency plans to place FDA staff in China over the next 18 months as part of its "Beyond our Borders" program, which is designed to build stronger cooperative relationships between the FDA's counterpart agencies around the world. The new FDA office in China will allow greater access for inspections and help ensure that drug products shipped to the U.S. meet safety and manufacturing standards.

In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

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