HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



US FDA's Consumer Health Oversight Absent From Appropriators’ Request For COVID-19 Assessment

House appropriators don’t mention the consumer health market in requesting a report on FDA’s response to COVID-19, but the agency’s frequent warnings about products marketed with unlawful claims could merit mentioning. Encouraging accelerated production of hand sanitizers while also ensuring the additional supplies are safe is another component of its COVID-19 response that could be covered in an assessment of its response to the pandemic.

US COVID-19 Fraud: Home-Use Fingerstick Collection Kits Promised Results Within 72 Hours

FDA warns Florida firm Modern Allergy Management and a testing lab abut an unapproved and mislabeled home-use fingerstick sample collection for COVID-19 test. The firm promised results within three days.

US COVID-19 Fraud: Licorice Promoted As Treatment, Unapproved Tests Offered OTC

FDA and FTC continue adding to total each has made during novel coronavirus pandemic. FTC's latest include peroxide gel and licorice as treatments; FDA’s emphasizes in warnings that three businesses' tests were not approved for OTC sales or for home use.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1131561

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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