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FDA Officials Speak Out: New Approvals & Safety Concerns Discussed

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“I’m not sure that we can provide any further guidance,” he said. “This is in the context of serious toxicities, based on a specifically designed safety study. I wish we had more of these to inform comparative safety and effectiveness for other products as well. That would provide much more meaningful answers to the questions that you’re raising.”

Thomas R. Collins is a freelance medical writer based in Florida.

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