Pink Sheet 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

Coronavirus Product Communications Would Get Safe Harbor Under Senate Bill

Executive Summary

In what could be the first major use of the Emergency Use Authorization pathway, manufacturers would be able to disseminate information based on ‘competent and reliable scientific evidence’ that is truthful, non-misleading and directed at population-level decision makers. The measure would define the CARSE standard in the FD&C Act for first time, attorneys say.

You may also be interested in...



Remdesivir EUA Includes Promotional Limitations Absent From Chloroquine Authorization

Printed materials and promotions must describe Gilead’s drug as authorized, not approved, for treating COVID-19; although similar boilerplate restrictions are part of most of the EUAs issued for diagnostics and equipment to combat the novel coronavirus, they were not included in the authorization for chloroquine/hydroxychloroquine. Remdesivir's new website strongly resembles an approved brand product site.

Drug Industry Perks Mostly Dropped From COVID-19 Bill, But A Big One Remains

Early versions of US Congress's coronavirus relief bill contained a number of policies that would have benefited drug firms, but they didn't make it into the final bill. However, the $2 trillion package does provide pharmaceutical companies with relief from the threat of drug pricing reform until after the 2020 elections.

Off-Label Promoter In Chief: President Trump Pushes COVID-19 Therapy

If the President says over and over again that a drug is approved, does that make it so?

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141897

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