Regulatory News In Brief
FDA transparency with industry: FDA is collecting information on ways it can improve transparency with regulated industries, the third phase of its ongoing transparency initiative. FDA says it held three listening sessions with members of regulated industry on Jan. 21, 27 and 28 and will publish transcripts of those sessions on the dockets. The agency seeks public comment on issues raised during the meetings and on how it can improve regulatory training and education for industry; guidance development; channels of communication with industry routinely and during crises; useful and timely answers to industry questions; and communications with sponsors during application reviews. Comments are due April 12
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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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AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
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.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.