Search Results for Adverse Event Reports

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FDA Launches Searchable Adverse Event Database for Drugs and Biologics By Michael Mezher - Published 29 September 2017

The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: FAERS, Public Dashboard, Adverse Event Reports

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices By Michael Mezher - Published 13 January 2017

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: News, Europe, US, EC, FDA, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Adverse Event Reports, AER, Safety

Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year By Zachary Brennan - Published 06 June 2016

In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic reported a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Swissmedic, adverse event reports, European drug regulators, Swissmedic

GHTF Releases Guidance on Adverse Event Data Reporting Standard By Alexander Gaffney - Published 02 August 2012

Categories: GHTF

Tags: N87:2012, SG2, N54:2006, XML, Adverse Event Reports, AER, Latest News

Canada's 2011 Adverse Event Data Shows Increasing Number of Reports By Alexander Gaffney - Published 12 July 2012

Categories: Health Canada

Tags: Serious Adverse Events, Adverse Event Reports, Trends, AERS, Adverse Events, Latest News, data