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NONPROFIT CALLS FOR INVESTIGATION OF SILICONE IMPLANT COMPANY
FDAnews - Sunday, October 22, 2006
A nonprofit called Oct. 12 for a criminal investigation into Mentor's "apparent failure" to send the FDA data that showed safety problems with its silicone gel ... more

MEDTRONIC ANNOUNCES LARGEST CLINICAL STUDY EVALUATING DRUG-ELUTING STENT SAFETY
FDAnews - Sunday, October 22, 2006
Medtronic said Oct. 19 it will begin the largest-ever clinical trial to assess the safety of its Endeavor drug-eluting coronary stent in comparison with a competitor's ... more

Full Issue in PDF Format
FDAnews - Sunday, October 22, 2006
View the entire issue in PDF ... more

Kenner residents report scammers (Reg Req'd)
Topix - Thursday, October 19, 2006
With three people reporting similar cons, Kenner police Monday warned of scammers offering counterfeit money orders and checks for many times the price of the items they seek to buy. Comment ... more

FIRMS, FDA NEED BETTER COMMUNICATION ON INSPECTION PROCESS, EXPERTS SAY
FDAnews - Wednesday, October 18, 2006
Devicemakers can help ensure smoother FDA inspections of their facilities by improving their communication with inspectors and making sure their regulatory affairs personnel fully understand the quality system regulation, experts ... more

Fleeing Fayose arrested at Idi-Iroko border - Now in SSS custody, to...
Topix - Wednesday, October 18, 2006
FLEEING Ekiti State governor, Mr. Ayodele Fayose, was reportedly arrested on Monday by a combined team of Customs men and operatives of the State Security Service at the popular Idi-Iroko border on his way to ... Comment ... more

NANOTECHNOLOGY DEVICE MARKET COULD LANGUISH WITHOUT ADEQUATE FDA FUNDING
FDAnews - Tuesday, October 17, 2006
Devicemakers can expect a slow approval process for devices that employ nanotechnology unless the FDA gets more funding to regulate the emerging field, experts ... more

FDA ISSUES WARNING ON COUNTERFEIT BLOOD GLUCOSE TEST STRIPS
FDAnews - Tuesday, October 17, 2006
The FDA said Oct. 13 it is alerting the public to counterfeit blood glucose test strips being sold in the U.S. for use with various models of LifeScan One Touch brand blood glucose monitors used by people with diabetes to measure their blood ... more

Wolf Chevrolet target of money-order scam
Topix - Sunday, October 15, 2006
BELVIDERE - Money-order scams are among the most common fraud schemes in the world, partly because they're easy to get away with. Comment ... more

Full Issue in PDF Format
FDAnews - Saturday, October 14, 2006
View the entire issue in PDF ... more


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Nanotechnology Device Market Could Languish Without Adequate FDA Funding
FDAnews - Saturday, October 14, 2006
Devicemakers can expect a slow approval process for devices that employ nanotechnology unless the FDA gets more funding to regulate the emerging field, experts ... more

Firms, FDA Need Better Communication On Inspection Process, Experts Say
FDAnews - Saturday, October 14, 2006
Devicemakers can help ensure smoother FDA inspections of their facilities by improving their communication with inspectors and making sure their regulatory affairs personnel fully understand the quality system regulation (QSR), experts ... more

Guidant Wins Again in Medtronic Patent Lawsuit
FDAnews - Saturday, October 14, 2006
Boston Scientific Oct. 12 announced that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against ... more

Nonprofit Calls for Investigation Of Silicone Implant Company
FDAnews - Saturday, October 14, 2006
A nonprofit Oct. 12 called for a criminal investigation into Mentor’s “apparent failure” to send the FDA data that showed safety problems with its silicone gel ... more

Firms Should Perform Early Safety Testing on Nanotech Products
FDAnews - Saturday, October 14, 2006
Firms should make safety research on nanoparticles a priority in their product design processes, because the FDA’s limited resources do not allow the agency to fully research the potential safety risks of nanotechnology, experts say (see related ... more

FDA Wants Injunction Against Devicemaker for Illegal Distribution
FDAnews - Saturday, October 14, 2006
The FDA announced Oct. 6 it is seeking a permanent injunction against Endotec for its illegal distribution of total joint replacement devices. Endotec has continued to distribute the devices despite warnings that it was breaking federal law, the agency ... more

Tips for Firms Responding To FDA Inspections
FDAnews - Saturday, October 14, 2006
A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer told D&DL (see related ... more

Briefs
FDAnews - Saturday, October 14, 2006
... more

FDA ISSUES DETAILED REQUIREMENTS FOR DEVICE REPROCESSORS
FDAnews - Saturday, October 14, 2006
Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent ... more

GUIDANT WINS AGAIN IN MEDTRONIC PATENT LAWSUIT
FDAnews - Saturday, October 14, 2006
Boston Scientific announced Oct. 12 that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against ... more

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