Patient safety, news and press releases from EMA
- Thu, 27 Oct 2016 14:30:00 +0000: News and press releases: EMA closed from 28 October to 3 November 2016 - News and press releases
EMA website and online applications unavailable from 28 October to 1 November 2016
- Wed, 26 Oct 2016 14:00:00 +0000: News and press releases: New search page for periodic safety update report single assessments (PSUSAs) - News and press releases
Simpler way to access outcomes for nationally authorised medicines
- Mon, 24 Oct 2016 14:00:00 +0000: News and press releases: Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November - News and press releases
EMA to check validity of submissions by end 2016
- Mon, 24 Oct 2016 13:00:00 +0000: News and press releases: How to make better use of patient registries to collect high-quality data on medicines - News and press releases
Workshop to be broadcast live on 28 October
- Thu, 20 Oct 2016 14:00:01 +0000: News and press releases: Opening up clinical data on new medicines - News and press releases
EMA provides public access to clinical reports
MedWatch Safety Alert RSS Feed
- Wed, 26 Oct 2016 15:00:00 +0000: TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results - MedWatch Safety Alert RSS Feed
The most recent post-approval study results assessing post-market performance is available.
- Tue, 25 Oct 2016 16:29:00 +0000: Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence - MedWatch Safety Alert RSS Feed
New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
- Mon, 24 Oct 2016 04:00:00 +0000: HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues - MedWatch Safety Alert RSS Feed
Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
- Thu, 20 Oct 2016 18:00:00 +0000: Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use - MedWatch Safety Alert RSS Feed
Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
- Thu, 20 Oct 2016 13:30:00 +0000: Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients - MedWatch Safety Alert RSS Feed
The FDA is concerned that health care providers may be unaware of the risks associated with these devices.