Search Results for emergency use authorization

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House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations By Zachary Brennan - Published 17 November 2017

The Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis.

Categories: News, US, FDA, Crisis management, Regulatory strategy, Submission and registration

Tags: NDAA, emergency use authorization

House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA By Zachary Brennan - Published 10 November 2017

The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected.

Categories: News, US, FDA, Drugs, In vitro diagnostics, Medical Devices

Tags: Department of Defense, emergency use authorization

FDA Sends Three Letters Over Unapproved Zika Diagnostics By Michael Mezher - Published 14 March 2016

The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics.

Categories: News, US, FDA, In vitro diagnostics

Tags: Zika, Zika virus, Emergency use authorization

FDA and EMA Share Perspectives on Evaluating Ebola Treatments By Michael Mezher - Published 18 January 2016

Officials from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shared their perspectives on evaluating treatments for Ebola in two articles appearing in Clinical Trials.

Categories: News, Africa, Europe, US, EMA, FDA, WHO, Biologics and biotechnology, Clinical, Drugs, Ethics, Postmarket surveillance, Preclinical, Regulatory strategy, Research and development, Submission and registration

Tags: Ebola, Emergency Use Authorization, Animal Rule, Conditional marketing authorisation, Accelerated Approval

US Preparedness for Public Health Emergencies: Medical Countermeasures and Emergency Use Authorization By Debra B. Feldman, MPH - Published 04 December 2015

This article discusses how medical products needed during public health emergencies can be made available to the public through the use of FDA's Emergency Use Authorization (EUA).

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Emergency Use Authorization, EUA, Public Health Emergencies, CBRN,

An Argument for Emergency Authorization During Public Health Crises By Michael Mezher - Published 09 March 2015

When a public health crisis like Ebola emerges, public health officials need the flexibility to respond quickly and effectively. But as a new paper in the journal Public Library of Science - Medicine (PLoS Medicine) argues, many countries currently have in place regulatory hurdles which would delay access to experimental new emergency treatments during such crises.

Categories: News, Africa, Europe, US, EMA, FDA, WHO, Ethics, Regulatory strategy, Submission and registration

Tags: Ebola, Emergency Use Authorization, Compassionate Use

Facing Enterovirus Outbreak, HHS Gives FDA Power to Authorize Use of Experimental Diagnostics By Alexander Gaffney, RAC - Published 27 February 2015

The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Submission and registration

Tags: Emergency Use Authorization, EUA, Emergency use Declaration, DHHS, Enterovirus D68

FDA Authorizes Sixth Device to Help in Fight Against Ebola By Alexander Gaffney, RAC - Published 14 November 2014

The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months.

Categories: News, US, CDRH, In vitro diagnostics, Submission and registration

Tags: Ebola, EUA, Emergency Use Authorization, Diagnostic

FDA Authorizes Use of New, Substantially Faster Ebola Diagnostic Tests By Alexander Gaffney, RAC - Published 27 October 2014

The US Food and Drug Administration (FDA) has granted emergency use authorizations (EUAs) to two new diagnostic tests meant to help health professionals to accurately diagnose the Ebola Zaire virus in record time.

Categories: News, US, FDA, In vitro diagnostics, Labeling

Tags: Ebola, EUA, Emergency Use Authorization, BioFire Defense, Diagnostic, IVD

FDA Formally Authorizes New Diagnostic Meant to Help Fight Against Ebola By Alexander Gaffney, RAC - Published 16 September 2014

The US Food and Drug Administration (FDA) has formally granted clearance to a testing device intended to be used to diagnose patients with the Ebola virus under special, emergency circumstances.

Categories: News, Africa, US, CDRH, In vitro diagnostics, Submission and registration

Tags: Ebola, EUA, Emergency Use Authorization, PAHPRA, TaqMan

FDA Again Exercises Rarely-Used Emergency Approval Authority By Alexander Gaffney, RAC - Published 20 June 2014

Citing continued risks to human health, the US Food and Drug Administration (FDA) has once again granted market access for an in vitro diagnostic device meant to detect the H7N9 influenza virus, using its emergency authority under a little-known law.

Categories: News, US, FDA, In vitro diagnostics

Tags: Emergency Use Authorization, H7N9, Emergency Use, Assay, Emergency Use Approval, PAHPRA

Threat of Flu Leads FDA to Grant Emergency Use Approval to New Diagnostic Test By Alexander Gaffney, RAC - Published 19 February 2014

Categories: US, FDA

Tags: Emergency Use Authorization, EUA

FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: US, FDA

Tags: Emergency Use Authorization, CDC, EUA, Emergency, Latest News, DHHS, virus, medical device