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

Warp Speed’s Woodcock Encourages Institutions To Continue COVID-19 Plasma Controlled Trial

Executive Summary

Seeking to prevent negative fallout from emergency use authorization, Woodcock and NIH Director Collins ask investigators to prioritize a controlled trial of convalescent plasma currently underway in outpatients.

You may also be interested in...



Convalescent Plasma EUA ‘Could Have Been Done Better’ But Not A ‘Total Catastrophe’ – FDA’s Marks

Expanded access program for COVID plasma grew bigger than FDA anticipated, and the agency should have pushed harder for randomized clinical trials earlier, CBER director says. Although unapologetic about the EUA, Marks regrets there was not a better understanding of product quality attributes at the time of authorization.

Email Trove From US FDA Shows Peter Marks As Champion For Plasma Authorization

The emergency use authorization for convalescent plasma in August 2020 on weak data from an expanded access program has largely been viewed as a politically charged decision by the Trump administration. But newly revealed emails from the run up to the decision indicate Center for Biologics Evaluation and Research Director Peter Marks backed the plan.

Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data

US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS142843

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