Focus Online » News

News

Search:  

Latest News | 14 May 2012

FDA Issues New Recommendations for MS Drug After Cardiovascular Concerns Raised

0 Likes

The US Food and Drug Administration (FDA) has placed new contraindications on Novartis’ Multiple Sclerosis drug Gilenya (fingolimod) after investigating the cases of several patients who died soon [Read More...]

Tags: Adverse Event Cardiovascular Contraindication drug FDA Gilenya MS Multiple Sclerosis Novartis Pharmaceutical Warning
Latest News | 10 April 2012

Report: New Troubles for Medical Device Manufactuers, FDA After Faulty Leads Lead to Questions

0 Likes

The medical device industry is being shaken by a series of issues involving St. Jude Medical’s defibrillator leads, reports The New York Times, leading to serious questions about transparency, [Read More...]

Tags: Adverse Event Defibrillator FDA Guidant Heart Lead Leads Medical Device Medtronic report St. Jude
Latest News | 5 April 2012

Paper Looks to Establish Best Practices for Evaluating Effectiveness of Regulations

0 Likes

A white paper released by Mini-Sentinel, and adverse event tracking pilot project, evaluates a series of existing studies evaluating the impact of the US Food and Drug Administration’s regulatory [Read More...]

Tags: Adverse Event Best Practices Evaluation FDA Mini-Sentinel Regulatory Study Tracking
Latest News | 26 March 2012

After Afghanistan Massacre, US Military Looks At Adverse Events

0 Likes

Top US Department of Defense (DoD) officials are ordering an emergency review of the adverse events surrounding the use of anti-malarial drug mefloquine after a US soldier allegedly massacred 17 [Read More...]

Tags: Adverse Event Afghanistan Anti-Malaria Army Lariam Malaria Marines Massacre Mefloquine Military
Latest News | 22 March 2012

DHHS Looks to Social Media for Warning Signals

1 Likes

A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools—specifically the micro-blogging website Twitter—to provide the agency with advanced signals to [Read More...]

Tags: Adverse Event DHHS Disease Signal Social Media Twitter
Latest News | 19 March 2012

FDA Seeks Feedback on Postmarketing Adverse Event Drug Reporting

0 Likes

The US Food and Drug Administration (FDA) is looking for feedback regarding its postmarketing adverse drug experience reporting system, including ways to make the system more efficient and less [Read More...]

Tags: Adverse Event FDA Postmarketing Reporting Review
Latest News | 9 March 2012

Study: Medical Device Safety Could Be Improved With Help of Software

0 Likes

A new study published in the American Health Association’s journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical [Read More...]

Tags: Adverse Event AE AHA American Heart Association ICD Leads Medical Device Reporting Study
Latest News | 15 February 2012

FDA Calls for Comments on Adverse Event Reporting for Medical Devices

0 Likes

The US Food and Drug Administration (FDA) is calling for medical device manufacturers, importers and facility owners to provide feedback on how FDA collects information related to reports of serious [Read More...]

Tags: Adverse Event Facility FDA Importer manufacturer Medical Device Reporting
Latest News | 3 February 2012

Reuters: French Regulatory Authority, Executives Searched In Mediator Probe

0 Likes

The offices of French regulatory authority Afssaps were searched by French investigators on 2 February as part of an investigation in to deaths associated with Servier’s anti-diabetes drug Mediator, [Read More...]

Tags: Adverse Event AFSSAPS Cardiovascular Deaths France French Investigation Mediator Searched Servier
Latest News | 9 January 2012

86% of Adverse Patient Events Go Unreported in Hospitals

0 Likes

The US Department of Health and Human Services’ (DHHS) Officer of the Inspector General (OIG) released a report on Friday, 6 January indicating that six in seven adverse events (AEs) that take place [Read More...]

Tags: Adverse Event AE AHRQ CMS DHHS OIG Reporting
1 2