1. Pink Sheet

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Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety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The agency issued draft guidance on 20 June describing the benefit-risk assessment it uses in evaluating applications for opioid analgesic...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

More from Agency Leadership