Edwards Lifesciences warning letter
This article was originally published in The Gray Sheet
Executive Summary
FDA cites quality system deviations, including complaint handling, documentation and training issues, in a warning letter to Edwards Lifesciences, announced Feb. 20. The warning, which stems from an inspection of the firm's Irvine, Calif., facility, notes that Edwards will not receive premarket approval for devices "reasonably related to those issues" until they are resolved. Edwards says the warning will not have a material impact in 2007 and it does not expect delays for product launches or clinical trials, including the U.S. pivotal trial for its Sapien transcatheter aortic heart valve, slated to begin this quarter. The firm continues to anticipate PMA approvals for its Magna mitral tissue valve and a superficial femoral artery indication for its LifeStent self-expanding stent by year-end (1"The Gray Sheet" Dec. 18, 2006, p. 11). Edwards is scheduled to meet with FDA regarding the warning letter in March...
You may also be interested in...
First Quarter Earnings in Brief
Edwards Lifesciences: FDA has formally accepted the company's response to a February warning letter citing quality system deviations, including complaint handling, documentation and training issues, at its Irvine, Calif., facility and will not defer approval of any pending PMA or export certificates for products manufactured there, the company announces during its April 23 earnings call (1"The Gray Sheet" Feb. 26, 2007, In Brief). For the first quarter of 2007, ended March 31, Edwards income was $33.2 million, down from $45.9 million in the first quarter of 2006. However, earnings were up 2.9% to $264.1 million. Heart valve sales grew 3.5% to $129.5 million led by sales of Magna tissue valve products outside the United States. Critical Care sales grew 12.1% to $90.9 million led by the FloTrac pressure monitoring system. Cardiac Surgery Systems sales were down about 28% to $16.8 million due primarily to Edwards' departure from the perfusion and transmyocardial revascularization markets..
U.S. Approval Of Edwards Sapien Transcatheter Heart Valve Possible In 2009
Edwards Lifesciences is on track to begin a U.S. pivotal trial in early 2007 for its Sapien transcatheter aortic heart valve, making FDA approval possible by late 2009, according to the company
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”