Search Results for Adverse Event Reporting

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Fast Facts: Serious Adverse Event Reporting Requirements in the US By Valerie Fauvelle, MS, RAC - Published 22 March 2017

This article presents reporting requirements for Serious Adverse Events (SAEs) and focuses on an important, but often overlooked regulation that specifies when a study is being run and includes the use of an approved drug. There are reporting requirements with specific timeframes that must be followed if there is a reportable SAE attributed to the approved drug.

Categories: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Adverse Event Reporting

European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016) By Nick Paul Taylor - Published 10 November 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices

Tags: Brexit, Big Data, regulatory science, social media, adverse event reporting

CBER Calls on HCT/P Manufacturers to Report Adverse Events Within 15 Days By Zachary Brennan - Published 08 March 2016

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases.

Categories: News, US, CBER, Biologics and biotechnology, Blood, Crisis management, Human cell and tissue, Postmarket surveillance

Tags: HCT/Ps, adverse event reporting, vascular graft, amniotic membrane

FDA Offers Draft Guidance on IND Safety Reporting By Zachary Brennan - Published 16 December 2015

For investigational new drug application (IND) sponsors running clinical trials and debating when a serious adverse event can be linked to an investigational drug and is serious enough to unblind data, FDA offered new draft recommendations on Wednesday.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Due Diligence, Government affairs, Postmarket surveillance, Preclinical

Tags: IND safety reporting, clinical trials adverse events, adverse event reporting, unblinding clinical trial data

Tufts CSDD Raises Questions over Adverse Event Reporting in US By Zachary Brennan - Published 16 September 2015

Inconsistencies in the way adverse event reports are filled out and sent to the US Food and Drug Administration (FDA) could mislead drug safety professionals and cause the wrong conclusions to be drawn, in addition to myriad other issues, according to a report from the Tufts Center for the Study of Drug Development released Wednesday.

Categories: News, US, FDA, Communication, Compliance, Drugs, Postmarket surveillance, Quality

Tags: adverse event reporting, ADEs, MedWatch, FDA, side effects

Managing Pharmacovigilance in Digital Health Initiatives Published 14 August 2015

This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives.

Categories: Articles, Features, US, FDA, Prescription drugs, Postmarket surveillance

Tags: pharmacovigilance, pharmaceutical, adverse events, adverse event reporting, digital health

EU Committee Takes on Adverse Event Reporting for Veterinary Drugs By Michael Mezher - Published 20 March 2015

Regulators at the European Medicines Agency (EMA) are concerned that adverse events may be underreported for veterinary drugs. In an effort to address the issue, the agency’s Committee for Medicinal Products for Veterinary Use (CVMP) has published a reflection paper intended to boost adverse event reporting.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance, Veterinary products

Tags: Adverse Event Reporting, AERs, Food-producing animals, CVMP, VICH

FDA, CDC Preparing Updated Form to Record Vaccination Problems By Alexander Gaffney, RAC - Published 24 November 2014

The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form.

Categories: News, US, CBER, Biologics and biotechnology, Postmarket surveillance

Tags: VAERS, VAERS 1.0, VAERS 2.0, Vaccine Adverse Event Reporting System, CDC, Centers for Disease Control and Prevention, Vaccine

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

For First Time Since Founding, Government's Mini-Sentinel System Shrinks in Size By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: MSDD, Big Data, Mini-Sentinel, Adverse Event Reporting, AER, Latest News

Australia’s TGA Launches Database of Adverse Event Notifications By Ansis Helmanis, RegLink - Published 19 June 2013

Categories: Regulatory Update, TGA

Tags: DAEN, Adverse Event Reporting, australia

EMA Launches EU-Wide Investigation into Roche for Alleged Pharmacovigilance Deficiencies By Alexander Gaffney, RF News Editor - Published 23 October 2012

Categories: EMA

Tags: ADR, Adverse Event Reporting, Roche, Reporting, ADE, Latest News, safety, pharmacovigilance, risk

EMA Slams Roche Over Extensive Safety Reporting 'Deficiencies' By Alexander Gaffney - Published 22 June 2012

Categories: EMA

Tags: ADR, Adverse Event Reporting, Roche, Reporting, ADE, Latest News, safety, pharmacovigilance, risk

Warning Letter Analysis: Siemens, Terumo Cited for Adulterated Devices By Alexander Gaffney - Published 20 June 2012

Tags: Terumo, Seimens, Warning Letter Analysis, Adulterated, Adverse Event Reporting, warning letter, Latest News, cGMP

Warning Letter Analysis: Companies hit for CGMP, Reporting Violations By Alexander Gaffney - Published 17 May 2012

Tags: Warning Letter Analysis, Adverse Event Reporting, warning letter, Latest News, cGMP

FDA Releases Guidance on Reporting Adverse Events During Flu Pandemic By Alexander Gaffney - Published 24 February 2012

Categories: FDA

Tags: Adverse Event Reporting, AER, Pandemic, Final Guidance, Influenza, Flu, Latest News, guidance