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:

• An up-to-date overview of REMS regulatory requirements, including how FDA public statements add to the growing knowledge base about what’s expected
• Lessons learned from early REMS
• Tips for preparing REMS to minimize regulatory delays
• Drug companies’ rights in fighting a REMS designation
• How to avoid the most common and costly mistakes in implementing REMS
• How government plans for expanding electronic health records affect REMS
• And more

Buy Now!
REMS 2.0: Strategies for Satisfying the FDA’s REMS Requirements is offered by FDAnews in print or PDF format for $397 each.

Act now: place your order here.

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Your risk is zero when you purchase under our money-back guarantee. Not satisfied with REMS 2.0: Strategies for Satisfying the FDA’s REMS Requirements? Return the hard copy within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.