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

Experts At US House Subcommittee Criticize FDA’s Initial Lack Of Serology Testing Oversight

Executive Summary

The FDA’s initial lack of oversight of the tests shows why it is important for the agency to continue its public health responsibility in ensuring safe and effective products get to market, a panel of experts told lawmakers.

You may also be interested in...



Not Renewing COVID-19 Public Health Emergency Could Have Serious Consequences: Lobby Group

Tests may need to be pulled from the shelves if the COVID-19 Public Health Emergency isn’t renewed before it would expire this month, device lobby group AdvaMed claims. But HHS has indicated plans to renew the order.

FDA Enters Public-Private Partnership To Evaluate COVID-19 Tests Amidst Concerns Over Efficacy

The US FDA is partnering with industry stakeholders and advocacy groups to investigate the long-term effectiveness of COVID-19 tests. The announcement follows recent moves by the agency to pull a slew of antibody tests from the market due to a high rate of false negatives and criticism from stakeholders, including lawmakers.

‘Email Me’: FDA Director Says He’ll Cut Through Red Tape To Ensure EUAs Are Assigned Liaison

As the number of emergency use applications (EUAs) for COVID-19 tests have mushroomed, the director of the US FDA’s in vitro diagnostics division says he’s directed his office to ensure all sponsors are assigned an agency liaison within two weeks of receiving a completed application. And if an officer isn’t assigned, Timothy Stenzel told sponsors to personally reach out to him so he can intervene on their behalf.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT142288

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