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

REMS And Benefits? FDA, Industry Debate Moving Beyond Safety Information

Executive Summary

Included in FDA's upcoming look at improving Risk Evaluation and Mitigation Strategies may be an adjustment to Medication Guides to include drug benefits alongside risks
Advertisement

Related Content

FDA “Reminds” Doctors To Talk About Drug Benefits
One-Page MedGuide For Long-acting Opioids Sets Stage For Retooling MedGuide Format
FDA's Long-Term Vision For REMS Includes "Plug-And-Play" Standardization
REMS 2.0: FDA Refining New Drug Safety Tools
REMS 2.0: FDA Refining New Drug Safety Tools
FDA Must Maintain Oversight Role In PMI Development, Groups Urge
Regulatory News, In Brief
REMS Templates Get Nod From FDA, With Nudge From Pharmacists
PhRMA Wants MedGuides Developed The Pre-FDAAA Way, Not Through REMS
Single Patient Drug Leaflet Logical, Complicated To Achieve - Woodcock

Topics

Advertisement
UsernamePublicRestriction

Register

PS052488

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