The US Food and Drug Administration will be evaluating whether proposed new opioid analgesics provide any advantages over existing pain therapeutics and could make it a requirement for approval. The agency also will be considering if a proposed product has any comparative safety and efficacy data.
New Opioids May Need Comparative Effectiveness Data For Approval
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
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