Regulatory News In Brief
FDA fundamentals: Agency launches its 1FDA Basics Web site Jan. 12 as the first phase of its transparency initiative. The site attempts to explain FDA operations, decision-making and product review processes in consumer-friendly language with question-and-answer sections and video conversations with agency personnel. It also will feature live online sessions with senior officials answering questions on various topics. FDA Basics includes a page for each FDA product section; the device page discusses the difference between the terms "clears" and "approves," and what recalls mean for implanted devices. The FDA Transparency Task Force plans to make recommendations to the commissioner for general transparency policy changes by the end of February. In the final phase of the initiative, the task force will make recommendations to regulated industries, probably by mid-year (2"The Gray Sheet" Nov. 16, 2009)
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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.
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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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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.
