Search Results for drug safety

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Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds By Zachary Brennan - Published 08 September 2017

The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found an association between these expedited pathways and the likelihood of safety-related labeling changes.

Categories: News, US, FDA

Tags: breakthrough drug, accelerated approval, fast track, drug safety, label changes

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk By Zachary Brennan - Published 06 June 2016

The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach.

Categories: News, US, FDA, Over the counter drugs, Postmarket surveillance

Tags: aspirin, heartburn, OTC drug safety communications, nonprescription drugs

MHRA: Safety Updates Will No Longer be Submitted to National EU Regulators Beginning in June By Zachary Brennan - Published 19 February 2016

From 13 June 2016 onward, companies across Europe will no longer submit periodic safety update reports (PSUR) to national regulators but instead to a central repository at the European Medicines Agency (EMA).

Categories: News, Europe, EMA, MHRA, Compliance, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PSUR, drug safety updates, pharmaceutical safety reports, EMA repository

Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System By Alexander Gaffney, RAC - Published 30 March 2015

In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks.

Categories: News, US, CDER, Drugs, Labeling

Tags: Generic Drug Labeling, Generic Drug Safety, Expedited Agency Review, EAR, PhRMA, GPhA

South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices By Stewart Eisenhart, Emergo - Published 17 March 2015

South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.

Categories: News, Korea, Clinical, Medical Devices

Tags: Emergo, Emergo Group, MFDSm South Korea, Ministry of Food and Drug Safety

MHRA Joins other UK Agencies on Consolidated Website By Michael Mezher - Published 29 January 2015

The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) this week announced major changes to its website meant to incorporate it more thoroughly into the UK government's main website. MHRA announced its plans to move from the old website ( to in April 2014. The new website launched on 28 January 2015 with a design that incorporates feedback from users on how they use the MHRA website and the Drug Safety Update system.

Categories: News, Europe, MHRA, Communication, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: GOV.UK, Website, #MHRAonGOVUK, Drug Safety Update

Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings By Alexander Gaffney, RAC - Published 27 June 2014

In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products.

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

Tags: Wikipedia, Drug Safety, Safety, Drug Safety Communication, Internet