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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...

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

 
• By Derrick Gingery

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

 
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US FDA Commissioner Makary Is Learning To Appreciate His Staff

 
• By Michael McCaughan

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

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.

More from Agency Leadership

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.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

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US FDA Could Seek Stronger Warnings On SSRI Antidepressant Risks During Pregnancy

 
• By Sue Sutter

Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."