Search Results for FAERS

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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

Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database By Michael Mezher - Published 29 August 2017

A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: FAERS, Adverse Drug Reactions, ADRs, Pharmacovigilance

FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta By Zachary Brennan - Published 18 October 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects.

Categories: News, US, CDER, Crisis management, Generic drugs, Due Diligence, Government affairs

Tags: Mallinckrodt, Lannett Company, FAERS, generic drug approval, extended-release generic drugs

Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes' By Alexander Gaffney, RAC - Published 29 July 2014

Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events?

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

Tags: Google, Adverse Event Reporting, FAERS, Adverse Event, Big Data

Adverse Event Database Identifies Two Drugs as Having Potential Safety, Efficacy Issues By Alexander Gaffney, RF News Editor - Published 16 May 2013

Categories: US, FDA

Tags: FAERS, efficacy, safety

FDA Lays out Plan for National Medical Device Surveillance System By Alexander Gaffney - Published 07 September 2012

Categories: FDA, CDRH, Postmarket surveillance

Tags: NMDSS, FAERS, UDI, Surveillance, Latest News, medical device