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New Opioids May Need Comparative Effectiveness Data For Approval

 
• By Brenda Sandburg

Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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.

Closeup of risk and benefit wooden blocks on seesaw against gray background - Image

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.

The agency issued draft guidance on 20 June describing the benefit-risk assessment it uses in evaluating applications for opioid analgesic drugs. Specifically, the guidance states that FDA will consider a...

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