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

From EUA To Full Approval: CDER, CBER Still Developing Transition Plans

Executive Summary

US FDA drug center is evaluating how to handle the end of the coronavirus public health emergency, which would mean unapproved products would no longer be available, but officials likely have plenty of time to consider options.

You may also be interested in...



Woodcock Outlines Priorities For Next US FDA Commissioner

Along with the pandemic, user fees, IT upgrades and nutrition issues should be at the top of the list, the acting commissioner said.

Woodcock Outlines Priorities For Next US FDA Commissioner

Along with the pandemic, user fees, IT upgrades and nutrition issues should be at the top of the list, the acting commissioner said.

After EUA, COVID Vaccine Sponsors Need Plans For Continuing Trials

EUA request should also include plan for a sponsor’s active follow-up for safety among individuals given the vaccine under EUA – including assessing deaths, hospitalizations and other clinically significant adverse events – to inform ongoing benefit-risk determinations to support the continued authorization, US FDA says in its finally-released guidance.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS143103

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