FDA’s use of the Risk Evaluation & Mitigation Strategy authority declined for the the third consecutive year. That is a remarkable trend, considering that the REMS have existed for just four years.
FDA was granted the formal authority to impose post-marketing risk management plans and clinical trials under the FDA Amendments Act...
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?