Remodeling REMS: FDA kicks off guidance series with draft on new framework
In the first of what’s expected to be a series of REMS-related advice for the industry, the FDA on Monday unveiled new draft guidance on how to improve the safety programs often attached to higher-risk drugs.
The 26-page draft lays out the FDA’s thinking to help sponsors design, implement and evaluate a risk evaluation and mitigation strategy, or REMS. The programs can, for example, require drugmakers to develop communication plans with patients and doctors, or take other steps to reduce potential safety issues.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
