FDA meta-analysis of clinical trials did not show an increased risk of MI associated with the use of abacavir.
UPDATED 02/28/2011. Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.
Product marketed as a dietary supplement contains sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
With the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.
Medtronic is eliminating up to 2,000 positions during the third quarter as part of a major restructuring it blames on softer markets.
The Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Revo MRI SureScan Pacing System (P090013).
Counterfeit dietary supplement contains tadalafil, sildenafil, and/or sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
FDA received a report about a brown area on the lens cover of an infant phototherapy light. Upon closer examination, the lens cover also had burned and melted areas from having been improperly positioned under the heating element of an infant warmer...
Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to NewbornsFebruary 22, 2011 6:32 am | by U.S. Food & Drug Administration | News | Comments
Risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs.
The FDA has down-classified medical device data systems (MDDS) from Class III into Class I via a final rule, which could help manufacturers compete with IT companies in this area.
Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the FDA says.
Potential for serious maternal heart problems and death.
Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
These test strips may give falsely low glucose results. False results may lead patients or health care providers to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading...
Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...
An FDA inspection of Tra & Accessories found failures in its control of design, purchasing and the warehouse environment for products, resulting in a warning letter.
Rep. Rosa DeLauro (D-Conn.) is “strongly urging” CDRH to hold an advisory committee meeting to release all available information on 10-year postmarket study results for saline breast implants and address issues with FDA oversight of the trials.
Hip joint deterioration can lead to symptoms such as pain, stiffness or difficulty walking. When symptoms do not respond to conservative treatment, patients may be advised to undergo total hip replacement or hip resurfacing...
Use of recalled product may lead to patient harm.
The report proposes potential actions for FDA's CDRH to facilitate the development, assessment, and regulatory review of innovative medical devices.
FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the Agency requests comments on the Innovation Pathway proposed under the report.
Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011February 8, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
The purpose of the public workshop is to solicit public feedback on select actions outlined in CDRH's Medical Device Innovation Initiative (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and...
CDRH recognizes that transformative innovative devices typically present new scientific and regulatory challenges. The Innovation Initiative supports the development of innovative products by addressing some of the barriers that can impede a product's...