Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Publishes Final Guidance For Developers Seeking EUAs For Monkeypox Tests, Grants First Approval To Quest

Executive Summary

The US FDA has issued guidance on its current thinking on enforcement policies for EUAs on monkeypox diagnostics, along with recommendations to help developers get their tests approved more quickly.

You may also be interested in...



CDRH 2022: Shuren Says COVID-19 Left Agency ‘Battle-Scarred’ But Also Wiser

The US Food and Drug Administration’s device center released its annual report, noting the challenges posed by monkeypox on top of the ongoing COVID-19 pandemic. The report also cites what the center sees as its accomplishments for the year.

Abbott Gets First Monkeypox Test EUA For Commercial Use

The US Food and Drug Administration has granted Abbott emergency use authorization for its monkeypox test, making it the first diagnostic to detect the virus to become commercially available.

US FDA Provides Monkeypox Update, Including Testing Protocols

The Centers for Disease Control and Prevention (CDC) is providing the non-variola orthopoxvirus test throughout its public health Laboratory Response Network. The diagnostic is currently the only FDA-cleared test to detect monkeypox.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145806

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel