1. Pink Sheet

CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave

 
• By Derrick Gingery

A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.

CBER reorg
CBER added a Division of Human Capital as part of its organizational changes. • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

Cell and gene therapies fueled a reorganization within the US Food and Drug Administration’s Center for Biologics Evaluation and Research, as staff prepare for an influx of applications.

CBER’s Office of Tissues and Advanced Therapies now has another branch to handle gene therapies (Gene Therapies Branch II), as well as a new Tissue Engineering Branch. OTAT also added a third General Medicine Branch as part of the reorganization, which was announced 3 January in a

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

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.