To date, the FDA has approved more than 100 Risk Evaluation and Mitigation Strategies (REMS) plans ranging from simple medication guides to complex, multi-part programs.
Now drugmakers can take advantage of the lessons learned from these early, successful REMS — and avoid substantial delays and serious problems that might arise while satisfying FDA requirements about product safety.
This concise FDAnews management report helps take the guesswork out of developing a REMS, whether you’re bringing new drugs to market, winning approval for new indications, or addressing emerging safety risks with an already-approved drug.
You’ll benefit from the lessons learned from past REMS — plus get expert guidance drawn from FDA public statements. From simple medication guides to the complex elements of multi-part programs, you’ll gain trouble-shooting insights into what’s working … and what’s not.
Buy now to get the clear, real-world guidance necessary for building your own FDA-satisfying REMS, including:
REMS 2.0: Strategies for Satisfying the FDA’s REMS Requirements is offered by FDAnews in print or PDF format for $397 each.
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