2008 March at Regulatory Affairs Syndicator

Archive for March, 2008

Reynolds Ads Say Tobacco Oversight Is Burden FDA Doesn’t Need - New York Times

Closed Published by Google Inc. March 31st, 2008 in Google FDA News, Regulatory Affairs

Support Grows for Tobacco BillWall Street Journal - 5 hours agoBy ANNA WILDE MATHEWS A long-stalled bill that would give the Food and Drug Administration the power to regulate tobacco products is picking up momentum in …Ohio Faith Leaders Call o…

Summary Information for: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 31st, 2008 in Regulatory Affairs

PDF format only. Topics: Glucose Monitoring

New Medical Products: Decellularized Allograft Heart Valve Approved

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recove…

Recalls and Safety Alerts: Fentanyl (Duragesic) Patches Recalled

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

Several brands of fentanyl transdermal patches are being recalled because they may have defects that could allow the fentanyl gel to leak out of the patch. If the gel touches patient’s or caregiver’s skin, it could cause respiratory depression and p…

Recalls and Safety Alerts: New Safety Warnings about Chantix

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depres…

Recalls and Safety Alerts: Early Communication on Adverse Events from Botox and Myobloc

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product w…

Recalls and Safety Alerts: New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher…

Preventing Medical Errors: Remembering to Re-Activate a Patients?s Defibrillator

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

A recent FDA article in the journal “Nursing2008″ describes the case of a patient who died, possibly of ventricular fibrillation, following elective surgery. This happened because after the procedure, his implantable cardioverter defibrillator (ICD)…

Preventing Medical Errors: Mixups between Insulin U-100 and U-500

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when pre…

Patients Are Asking: Caution Giving Children Cough and Cold Medicines

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA is cautioning parents and caregivers about giving their children cough and cold medicines.

FDA strongly recommends that cough and cold medicines NOT be given to children younger than 2 years old because serious and potentially life-threateni…

Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar (Notice of public seminar).

Closed Published by Food and Drug Adminstration (FDA): CDRHNew March 31st, 2008 in Regulatory Affairs

The Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed’s Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device…

Eli Lilly Spent $4.36 Million Lobbying the Federal Government on Drug Issues in 2007 (Canadian Business)

Closed Published by Yahoo! News Search Results for Food and Drug Admin March 31st, 2008 in Yahoo FDA News, Regulatory Affairs

WASHINGTON (AP) - Drugmaker Eli Lilly & Co. spent $4.36 million last year lobbying the federal government on various prescription drug issues. The Indianapolis-based company lobbied on legislation affecting user fees companies pay the Food and Drug Administration to review their drugs.