1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Patient Experience Data May Require Separate Label, Genentech Suggests

 
• By Sue Sutter

US labeling for Genentech's Rituxan Hycela appears to have broken new ground with a 'Patient Experience' section describing summary data from a patient preference study; however, the company's global head of outcomes research says large volumes of patient-centric data would be difficult to reflect within the current labeling framework.

Data Collection - Three Arrows Hit in Red Target

The increasingly patient-centric approach to drug development and regulation may necessitate the development of separate product labeling for patients, one industry researcher believes.

Speaking at a Sept. 18 workshop on the US FDA's benefit/risk assessment framework, Alicyn Campbell, global head of Patient-Centered Outcomes Research for Oncology Product Development at Genentech Inc., questioned...

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

More from Agency Leadership