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

COVID-19: FDA Official Announces 200 EUAs, Clarifies Human Factors Testing Rules

Executive Summary

The US FDA’s diagnostics chief also addressed school screening and post-pandemic approval plans during a recent webinar.

You may also be interested in...



COVID-19: More Virtual Town Halls From FDA Through August

More webinars are on the way from the US agency that are aimed at labs and manufacturers that are (or have) developed diagnostic tests for the novel coronavirus.

FDA Greenlights Second Pooled Sample COVID-19 Test As Crucial Tool To Reopen US Economy

US regulators have re-issued an EUA to LabCorp’s COVID-19 molecular diagnostic test for pooled sampling. While the method could speed up testing and use less resources, it also can result in false negatives.

Antibody Testing During And After The Pandemic: Not All Tests Are Created Equal

While the main role of SARS-CoV-2 antibody testing is currently limited to determining exposure to the virus in populations, the scientific community is working hard to define the neutralizing properties of the antibodies detected, and the duration of the immune response. As a result, antibody testing could be here to stay for the long term for monitoring populations, testing vaccines and selecting patients for trials of a variety of new therapies to treat numerous conditions.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142542

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