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.