Pink Sheet 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

Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?

Executive Summary

Sponsors seek clarity about the transition process, which could last a year or longer.

You may also be interested in...



‘The Pandemic Is Over’? Not For US FDA

President Biden’s informal declaration that the COVID-19 pandemic is ‘over’ likely portends a formal end of the Public Health Emergency. But many of the US FDA’s COVID flexibilities don’t directly depend on that decision.

UPDATED: Who Can Sign US FDA EUAs? Expect Center Directors And Their Deputies Going Forward

Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.

Is Even The Pharma Industry Over COVID-19 Already?

Data suggests fewer approvals and new product ideas, as the business case for new generic and brand treatments seems to be tougher to make now than at other times during the pandemic.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS145743

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