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

The Limits Of REMS: Opioid Debate Shows Shortcomings Of New FDA Powers

Executive Summary

An FDA advisory committee's discussion of an agency proposal to manage the risk of long-acting/extended release opioids underscores the limits of the agency's authority to curb misuse of prescription medications even with the new safety powers enshrined in the 2007 renewal of the user fee legislation

You may also be interested in...



If Opioid REMS Mandates Prescriber Training, Firms May Ask DEA For Help

If FDA decides to incorporate mandatory prescriber training into a Risk Evaluation and Mitigation Strategy for extended-release opioids, industry implementation options include setting up an industry-wide registry or seeking congressional action to tie training verification into a Drug Enforcement Administration registry

If Opioid REMS Mandates Prescriber Training, Firms May Ask DEA For Help

If FDA decides to incorporate mandatory prescriber training into a Risk Evaluation and Mitigation Strategy for extended-release opioids, industry implementation options include setting up an industry-wide registry or seeking congressional action to tie training verification into a Drug Enforcement Administration registry

FDA Launches Safe Use Initiative; Details To Evolve Through Stakeholder Input

Vast scope of project - which will examine everything from operating room procedures to pharmacy leaflets - contrasts with "small" goals for the first year.

Related Content

Topics

UsernamePublicRestriction

Register

PS052491

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