Regulatory News In Brief
FDA may post 'untitled' letters online: FDA is considering posting on its Web site "untitled" letters issued to manufacturers. "In an era of enhanced enforcement and greater transparency, that's being discussed," according to Larry Spears, deputy director of regulatory affairs in CDRH's Office of Compliance. His comments came during FDAnews' recent Fourth Annual FDA Inspections Summit in Bethesda, Md. Currently, the agency only posts redacted warning letters online. "Untitled letters don't really meet the threshold of a warning letter," Spears said. "That means they're not significant enough that we would take a follow-up action necessarily with what we see, but there are problems that need to be identified to the company because we've looked at the evidence and believe there are problems. So we want to identify those in an untitled letter.
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A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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