For the second time in six years, FDA has received a clear directive from its external experts that opioid prescriber education should be mandatory, not voluntary, under the Risk Evaluation and Mitigation Strategy for extended-release/long-acting products.
On May 4, all 30 members of two advisory committees – Drug Safety and Risk Management, and Anesthetic and Analgesic Drug Products – voted in favor of modifying the REMS rather than
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?