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

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

Executive Summary

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

You may also be interested in...



Everything REMS Under The Sun: FDA Lays Out Ambitious PDUFA V Meeting Agenda

The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.

Paging Dr. McClellan: FDA Calls On Brookings For PDUFA Research

Brookings’ Engelberg Center for Health Care Reform invited to help FDA research REMS and risk-benefit standardization, patient-reported outcomes, and other issues that were mandated in PDUFA V.

Buying Time: Industry Sacrifices Early To Gain Later With PDUFA V Review Model

NMEs and novel biologics will see reviews allotted two additional months under the revised model launching Oct. 1. Industry expects to gain more communication and first-cycle approvals, while FDA hopes it can receive more complete applications at submission and improve transparency.

Related Content

Topics

UsernamePublicRestriction

Register

PS052146

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