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

Sponsors Can Expect REMS Discussions As Early As Phase II, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Though REMS requirements caused longer reviews in 2008, FDA Deputy Director Office of New Drugs Sandra Kweder said the agency expects "we will be doing this better and it will not affect PDUFA deadlines" going forward.

You may also be interested in...



REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice

The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program

REMS Reform Looks To Be Theme Of PDUFA V: Stakeholders Call For Standardization, Earlier Notice

The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program

Priority Review's Luster Dims In "Safety First Era" But Retains Value - Parexel

Sponsors of the most innovative new drugs should not be deterred by the apparent reversals of fortune for new molecular entities with priority review status in the last year, the consulting firm Parexel concludes in a new report

Related Content

Topics

UsernamePublicRestriction

Register

PS142351

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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