Pink Sheet is part of the Business Intelligence Division 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

US FDA’s REMS Reluctance On Display At Recent Advisory Committees

Executive Summary

Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.
Advertisement

Related Content

Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression
Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption
Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee
Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern
Evenity Likely Headed For Approval With Amgen's Proposed Indication, But Postmarketing Requirements Remain Unclear
Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely
Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS124641

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