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 Being ‘More Liberal’ On Accelerated Approval, Novavax Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Advisory committee likes alternative trial designs, but says more data is needed on immune markers.

You may also be interested in...



Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says

Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.

Arbor Emphasizes Risks Of Its Own Product In Suit Against US FDA To Block Nymalize Generics

FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.

CooperSurgical Lands US FDA Warning Letter Over ParaGuard TV Spot

The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.

Topics

Related Companies

UsernamePublicRestriction

Register

OM010563

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