1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

US FDA's Benefit-Risk Assessment Could Include More Emphasis on Patient Involvement

 
• By Brenda Sandburg

Agency aims to centralize and better communicate its assessments; stakeholders discuss involving patients early in drug development and offer suggestions for 2020 draft guidance.

Balance with risk benefit, pros and cons, 3d render illustration

The US Food and Drug Administration's development of a new approach to assessing the benefits and risks of drugs throughout their life cycle dovetails with efforts to better integrate patient feedback into product review and development.

FDA officials discussed how the agency is enhancing its framework for benefit-risk assessment at a 16 May public meeting convened...

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 Approval Standards

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
• By Derrick Gingery

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

More from Pathways & Standards