U.S. Pharmacist

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FDA Releases Stent Recommendations

Staff

5/20/2008

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

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.

 

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U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

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