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    FDA launches FAERS dashboard for COVID-19 therapies

    The US Food and Drug Administration (FDA) has launched a new public dashboard to track adverse event reporting for drugs and therapeutic biological products that have received emergency use authorization (EUA) to treat COVID-19.   The FDA Adverse Event Reporting System (FAERS) public dashboard for COVID-19 EUA products will be updated weekly, according to FDA’s landing page for the new initiative.     In its inaugural week, the dashboard indicates that a total ...
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    Switch in Adverse Event Reporting Forms Increased Quality and Quantity of Reports, FDA Study Finds

    Since 1969, health professionals and consumers have been able to voluntarily report pharmaceutical adverse events to FDA’s Adverse Event Reporting System (FAERS), and with a shift to plain language in the latest reporting form, a new study co-authored by FDA officials found that the quantity and quality of the adverse event reports has improved. The shift in mid-2013 to this plain language reporting form, known as the consumer voluntary reporting (ConVR) form or Form F...
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    FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

    The US Food and Drug Administration (FDA) on Thursday warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Sanofi’s Lemtrada (alemtuzumab). In the nearly five years since FDA approved Lemtrada to treat relapsing forms of MS, the agency said it identified 13 worldwide cases of ischemic and hemorrhagic stroke or arterial dissection that occurred short...
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    FDA Launches Searchable Adverse Event Database for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics. Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths , whether they were linked to the drug's safety...
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    Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database

    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. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...
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    FDA Proposes to Withdraw Two Generic Versions of ADHD Drug Concerta

    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. The manufacturers of the two Concerta generics - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Ma...
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    Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes'

    Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events? In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that "Internet search logs" could be substantially useful to the agency's drug regulatory staff in determining which drugs might have unforeseen adverse events. Background At present, FDA tracks those adverse events through a hybrid voluntary/mandatory rep...
  • Adverse Event Database Identifies Two Drugs as Having Potential Safety, Efficacy Issues

    A just-released update of the US Food and Drug Administration's Adverse Event Reporting System (FAERS) indicates that two drugs, metroprolol succinate extended release and serotonin-3 receptor antagonist products, are on the agency's radar for potential problems. The FAERS update, which covers the period between January and March 2013, identified two problems, both of which have not yet led to regulatory action but are nevertheless leading to continued study and evalua...
  • FDA Lays out Plan for National Medical Device Surveillance System

    On the eve of several public meetings aimed at reworking the US Food and Drug Administration's (FDA) medical device postmarket surveillance system, the agency has released a new plan it says offers its own roadmap on how to improve safety monitoring of potentially dangerous devices. The report, entitled, " Strengthening our National System for Medical Device Postmarket Surveillance ," proposes four changes to be made to the current system of postmarket surveillance: th...