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