Missing Data Hinders Inclusion Of Patient Experience In Drug Labeling, US FDA Says

Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.

Patient data
Missing data on trial endpoints can limit drug label claims • Source: Shutterstock

One of the challenges US Food and Drug Administration reviewers face is missing data in sponsor applications, particularly data on trial endpoints needed for a labeling claim.

FDA’s Michelle Campbell, senior clinical analyst for stakeholder engagement and clinical outcomes in the Office of Neuroscience, highlighted this problem...

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

More from US FDA

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

More from Agency Leadership

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.