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

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

Executive Summary

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.

You may also be interested in...



Immunogenicity Data Drove Monkeypox Dose-Sparring Decision…It Also Drove Initial Approval

Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.

Clinical Trial Diversity Campaign Distracting From Health Equity Problems, Califf Says

The FDA commissioner says that improving health disparities would fix the lack of diversity in clinical trials.

Novavax EUA Justified By US FDA With Claims Of COVID Vaccine Supply Constraints

The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS146851

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