Renal Business Today

U.S. Food And Drug Administration (FDA)

FDA clears Spire long-term dialysis catheters

BEDFORD, Mass.--The U.S. Food and Drug Administration gave Spire Corp. clearance to market the company's silver-coated hemodialysis catheters, Spire announced today. ...More
September 21, 2006
Posted in News, Business, Clinical & Pharma, Government & Regulation, Practice Management
Cardinal Health stops pump production after FDA seizure

DUBLIN, Ohio--Cardinal Health said Monday it has suspended production and sales of its Alaris SE drug infusion pump after the U.S. Food and Drug Administration seized more than 1,000 devices Friday. ...More
August 28, 2006
Posted in News, Clinical & Pharma, Government & Regulation
FDA seeks comments on medical device identifier system

WASHINGTON--The U.S. Food and Drug Administration is seeking information on how the use of a unique identifier system for medical devices may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting. ...More
August 10, 2006
Posted in News, Government & Regulation, Practice Management
FDA approves seasonal flu vaccines

WASHINGTON--The U.S. Food and Drug Administration announced it has approved this year's seasonal influenza vaccines that include the new strains of virus judged likely to cause flu in the Northern Hemisphere in 2006-2007. ...More
August 3, 2006
Posted in News, Clinical & Pharma, Government & Regulation
Genzyme Says Petition Against Renagel ‘Inaccurate’

CAMBRIDGE, Mass.—A recent petition to the U.S. Food and Drug Administration calling for the withdrawal of Genzyme Corp.’s phosphorus drug Renagel was characterized as “inaccurate” by a Genzyme spokesman. “This is a deliberate attempt by a competitor to distort the safety ...More
July 20, 2006
Posted in Articles, Business, Clinical & Pharma, Government & Regulation, Practice Management
Roxane recalls kidney transplant drug

COLUMBUS, Ohio--Roxane Laboratories Inc. has recalled a single manufacturing lot of the kidney transplant drug Azathioprine because the company found Methotrexate tablets in one bottle. ...More
July 13, 2006
Posted in News, Clinical & Pharma, Government & Regulation, Practice Management
Baxter, FDA reach agreement over seized pumps

DEERFIELD, Ill.--Baxter Healthcare Corp. has come to terms with U.S. Food and Drug Administration safety concerns about three types of infusion pumps in an agreement that will allow the company to resume sales of new infusion pumps in the United States if certain ...More
June 29, 2006
Posted in News, Business, Clinical & Pharma, Government & Regulation, Practice Management
Aksys receives FDA warning letter about dialysis machine

LINCOLNSHIRE, Ill.--Aksys Ltd. has received a warning letter from the U.S. Food and Drug Administration about it's marketing of the Personal Hemodialysis System, according to a June 20 company release. ...More
June 20, 2006
Posted in News, Business, Government & Regulation, Practice Management
FDA looks to reduce medicine abbreviation errors

WASHINGTON--The U.S. Food and Drug Administration and the Institute for Safe Medication Practices launched today a nationwide healthcare professional education campaign aimed at reducing the number of common but preventable sources of medication mix-ups and mistakes caused ...More
June 14, 2006
Posted in News, Clinical & Pharma, Government & Regulation, Practice Management
Imaging drug might cause disease in CKD patients

ROCKVILLE, Md.--The U.S. Food and Drug Administration said it has learned of 25 cases in Europe of a disease unique to kidney disease patients who have been injected with special drugs used to distinguish tissues and blood vessels during imaging procedures, according to an ...More
June 9, 2006
Posted in News, Clinical & Pharma, Government & Regulation, Practice Management