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REMS Redesign: FDA's Opening Statement to Stakeholders

 
• By Michael McCaughan

Center for Drug Evaluation & Research Director Janet Woodcock kicked off FDA’s two day feedback meeting on the REMS July 27 with a construction analogy: FDA is still in the process of building a new house, but it is clear that there needs to be a redesign. Here are her opening remarks, from the official transcript of the meeting.

We've had about two and a half years of experience with the FDA Amendments Act REMS provisions. We've heard concerns about the program from many affected parties, from industry, from prescribers, from pharmacy groups, patient groups and others. So we realize this program is not perfect. It's not meeting all the needs of all the groups involved. And it's on everyone's list to discuss as a part of PDUFA-V.

But in the meantime, we have to continue to approve drugs, and we need risk management programs for some of those drugs. So while we are continuing construction of the...

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