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Stents, tiny wire mesh tubes designed to shore up arteries, enjoy widespread use by surgeons. But these same devices in 2006 came under increasing scrutiny as emerging clinical trial results indicated that drug-eluting stents to treat heart disease, in particular, carry with them a potential risk for thrombosis, or blood clotting. The two manufacturers of drug-eluting stents currently on the U.S. market, Johnson & Johnson and Boston Scientific, scrambled to counter a growing public perception that their devices, the Cypher and the Taxus, might carry a rare but significant safety risk. Meanwhile, smaller manufacturers are learning from the struggles of their larger competitors and working to design devices that diminish that risk. The FDA in December held an important panel meeting to examine the available clinical evidence on drug-eluting stents, and concluded that wider patient populations will need to be studied to arrive at a decision on drug-eluting stent safety. The agency also may seek to curb off-label use of drug-eluting stents through stricter labeling for particular patient populations, such as those suffering from multivessel disease. Signs indicate that a sizeable percentage of physicians are backing away from drug-eluting stents in favor of the more traditional bare-metal stents — especially given the typical decline in rates of patient compliance with anti-clotting regimens the longer the drug-eluting devices remain implanted. As 2007 begins, analysts are watching to see how stent manufacturers will respond to the tide of negative publicity from these recent revelations.
The FDA’s Blood Products Advisory Committee has recommended that the agency not lift the clinical hold it has imposed on a clinical trial of Biopure’s blood substitute, Hemopure.
A key committee is recommending that the Centers for Medicare & Medicaid Services (CMS) soften a controversial proposal to require clinical trials it covers to enroll representatives of the populations Medicare serves.
The FDA, European regulators and industry are struggling to agree on a standard for the amount of data sufficient for sponsors to submit drug applications — a key obstacle to widespread use of adaptive trial designs, sources say.
The FDA, European regulators and industry are struggling to agree on a standard for the amount of data sufficient for sponsors to submit drug applications — a key obstacle to widespread use of adaptive trial designs, sources say.
Citing an increasing number of requests to conduct global clinical trials in India and the desire to ensure that the Indian entrepreneurs grab this opportunity, Indias Office of Drug Controller General (DCG) has outlined new procedures for handling clinical trial applications.
The FDA, European regulators and industry are struggling to agree on a standard for the amount of data sufficient for sponsors to submit drug applications — a key obstacle to widespread use of adaptive trial designs, sources say.
In the latest setback in VaxGen’s efforts to fill a government contract to develop a vaccine for anthrax, the company said that the FDA has placed a planned clinical trial of the product on clinical hold.
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) is in need of new leadership, as Ernest Prentice is stepping down as chairman.