FDA

Third Wave receives FDA clearance of pharmacogenetic test

It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy. The test is c...

FDA approves Bone Cares Hectorol for treatment of kidney disease

Middleton, Wis. -- announced Monday the U.S. Food and Drug Administration approved a new indication and strength for Hectorol (doxercalciferol) Capsules. Hectorol, a pro-hormone vitamin D2 analog, is currently approved for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients in the United Sta...

Reforming FDA: Focus on safety, let market judge efficacy

The primacy of efficacy over safety seems to be so deeply integral to the system that it mig...

FDA: Tortoise, hare, or something else?

In...

FDA approves GE's heart-imaging technology

The technology is based on compu...

Kyron wins FDA approval for brain imaging technology

Approval from the Kyron C...

FDA okays new GE tomography system

The company announced Thursday it has received clearance from the Food and Drug Administration for its new wide bore computed tomography (...

FDA approves advanced digital mammography system

The system offers more evidence that the medical community is moving to adopt digital mammography tools that enable higher quality images for the detection of breast cancer. With...

FDA programs encourage and expedite drug development and approval

Nearly half of all products produced by biotech companies are for orphan diseases. Two of the large...

Neurognostics receives special FDA clearance for MindState fDAD

., a Wisconsin company specializing in functional Magnetic Resonance Imaging (fMRI) products and services, announced today that the Food and Drug Administration (FDA) issued a Special 510(k) approval for market clearance of its trademarked MindState fDAD. MindState fDAD had previously received clearance in Febr...

U.S. FDA Clears GE Healthcare's New Bone Density System

Lunar iDXA, a new bone mineral density system designed to help doctors detect, diagnose and monitor treatment of osteoporosis, a disease characterized by low bone mass and increased risk of fracture, more accurately and earlier in the disease process. The system also ena...

On track with the FDA -- But what about your coverage and reimbursement strategy?

"Coverage" is whether there will be payment by an insurer for the product. "Reimbursement" is how much payment there will be if there is coverage. Unlike...

It's in the mail -- Responding to an FDA warning letter

Warning letters provide wr...

Who's that knocking at the door? Preparing for an FDA inspection

FDA enforces...

Challenging times for FDA and drug companies equals IT opportunities

One of the biggest challenges has been the pipeline problem, the slowdown instead of the expected acceleration in innovative...

Third Wave to seek FDA clearences after expanding pipeline

The company said revenue in 2005 would probably be driven primari...

Fast Track: FDA User Fees: Do Faster Review Times Justify the Financial Burden?

The Food and Drug Administration (FDA) recently began requiring applicants to pay significant user fees when filing applications in connection with new medical devices and biologics. Such user fees have long been required for drug-related applications, and now also are required for applications related to devices and biologics. In theory, user fees enable FDA to speed up application review time,...

GE Medical Systems Receives FDA Clearance for New MRI System

WAUKESHA, WI - GE Medical Systems, a unit of General Electric Company, announced today that it has received clearance by the U.S. Food and Drug Administration to begin marketing its new 3.0 Tesla ultra-short magnetic resonance imaging (MRI) system. The Signa EXCITE 3.0T combines the increased speed and higher resolution of an ultra-high field system with the breadth of imaging capabilities found...