HBW 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

Seeing Covid-19 Health Care Marketplace Opportunities? Look First For Regulatory Barriers

Executive Summary

Offering OTC tests for determining exposure to Covid-19, the disease caused by the novel coronavirus spreading worldwide, didn't go unnoticed for long in the US because the FDA hasn’t authorized any OTC test.

You may also be interested in...



US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use

OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.

Federal Agencies Shut Down Church Group's Sales Of Bleach Mixture Promoted As COVID-19 Cure

The combination of Genesis II Church's rejection of FDA's warning, the potential for serious adverse events linked to its chlorine dioxide formulation and its claims the product treats COVID-19 led FDA to seek an injunction to stop sales of the product a week after it warned the group.

Sanofi Developing COVID-19 OTC Test For Global Roll-Out

Sanofi has teamed up with Silicon Valley's Luminostics to develop a smartphone-based OTC test which can detect the COVID-19 virus. 

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS149836

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