3 agencies to assess problems with Lasik Oct 21, 2009
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says the study likely will identify which patients are at higher risk of poor outcomes and "could lead to a reduction" in those whose eye problems are made worse by the procedure. Type Size. (AZCentral -- Business)
FDA Acknowledges Mistakes in Knee-Device Approval Sep 30, 2009
"This device has been approved by the FDA, and we have no basis to question the safety of this device so it will remain on the market," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said during the teleconference ... SOURCES: Sept. 24, 2009, teleconference with Joshua Sharfstein, M.D., principal deputy commissioner, U.S. Food and Drug Administration, and Jeffrey Shuren, M.D., acting director, Center for Devices and Radiological Health, FDA. (MEDLINEplus)
Vermillion ovarian cancer test wins FDA OK Sep 15, 2009
Tests such as OVA1 personalize and improve public health by providing patients and health-care providers with more information to support medical decisions that impact survival rates and reduce surgical complications, Dr. Jeffrey Shuren, acting director of the FDA s Center for Devices and Radiological Health, said in a press release. OVA1 tests for levels of five proteins that change due to ovarian cancer. (East Bay Business Times, CA)
FDA Clears a Test for Ovarian Cancer Sep 12, 2009
"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health. The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. (PR Newswire)
• 1995: The Michael Jackson column (PDF) Sep 10, 2009
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Rub contact lenses clean Jun 29, 2009
The letter is not an official enforcement action, but asks the companies to come in to discuss the new data on lens cleaning, said Dr. Dan Schultz, director of the FDA Center for Devices and Radiological Health. E-mail health questions to. (Boston Globe)
Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH) Jun 23, 2009
The Center for Devices and Radiological Health (CDRH) at the FDA encourages sponsors to use innovative Bayesian designs for clinical trials involving device products. The Bayesian approach provides a natural way to combine prior evidence with current data. (PR Newswire)
LASIK ads must warn consumers of risks: FDA May 23, 2009
"Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading," wrote Timothy Ulatowski, head of the Office of Compliance for the FDA's Center for Devices and Radiological Health. advertisement. (MSNBC -- Health)
FDA approves rapid test for H5N1 virus in humans Apr 8, 2009
"This test is an important tool to help quickly identify emerging H5N1 infections and reduce exposure to large populations," said Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health. "The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.". (Xinhuanet, China)
False start on a laser remedy for fungus Mar 20, 2009
But Timothy A. Ulatowski, director of compliance at the Center for Devices and Radiological Health at the F.D.A., said companies were legally allowed to market a medical device only for the specific use for which it had been granted clearance. Selling or promoting a device for unapproved indications is illegal, he said. (International Herald Tribune -- Business)
FDA Experts to Speak at RAPS Horizons Conference Mar 20, 2009
Linda Ricci, biomedical engineer, Center for Devices and Radiological Health, FDA, Telemedicine: Getting Connected, 10:30 am-12:00 pm. Murray Malin, medical officer, Center for Devices and Radiological Health, FDA, Health Hazard Analysis in the Global Marketplace: Advice from the Experts, 1:30-3:00 pm ... Erica Takai, PhD, scientific reviewer, Center for Devices and Radiological Health, FDA, Harmonization by Doing: Medical Device Development in Japan, 1:30-3:00 pm. (PR Newswire)
Report: FDA scaled back enforcement at labs Feb 20, 2009
Medical devices are overseen by an FDA division called the Center for Devices and Radiological Health ... FDA's Center for Devices and Radiological Health ... FDA's Center for Devices and Radiological Health. (Yahoo News)
Inspections at medical device labs scaled back Feb 19, 2009
Medical devices are overseen by an FDA division called the Center for Devices and Radiological Health. The center has been shaken by recent complaints from its own scientists that managers squelched debate, leading to the approval of devices that were of questionable effectiveness and perhaps not entirely safe. (MSNBC -- Health)
US group decries fewer FDA device inspections Feb 19, 2009
A number of FDA scientists have complained that the agency's Center for Devices and Radiological Health (CDRH) stopped requiring device makers to undergo FDA preclinical lab inspections. Under FDA regulations, companies must submit a safety study of their device and show compliance with the FDA's Good Laboratory Practices guidelines before getting approval to start clinical trials. (Reuters)
FDA Approves First Atrial Fibrillation Ablation Catheters Feb 10, 2009
Dr Daniel G Schultz, director of the FDA's Center for Devices and Radiological Health said the FDA approval gives doctors another option for treating this "common and potentially debilitating condition". Atrial fibrillation is usually treated with medication, and in severe cases, open heart surgery is also an option. (Medical News Today)
