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
UsernamePublicRestriction

Ebola Vaccines: FDA Weighs Alternative Study Designs, Approval Pathways

This article was originally published in The Pink Sheet Daily

Executive Summary

As incidence of Ebola declines, advisory committee will consider alternatives to randomized controlled trials – an approach FDA had previously argued was inappropriate.

You may also be interested in...



Regulatory Briefs: Ebola Trials Protocol, AstraZeneca Resubmits Iressa

FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.

US FDA’s ‘Bad Ad’ Program Snares Paragard Contraceptive TV Video Promo

CooperSurgical is hit with second letter for misleading promotion of its copper-containing intrauterine contraceptive. Video lacked any safety information, agency says in request for corrective communication.

COVID-19 Vaccine Manufacturers Are Not Enthusiastic About Using Defense Production Act

Pfizer and Moderna execs note they have sufficient resources with their partners to meet their vaccine production commitments. J&J, which has a manufacturing arrangement with Sanofi, is ready to ship four million doses of its vaccine upon receiving authorization from FDA.

Topics

Related Companies

UsernamePublicRestriction

Register

OM017181

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