1. Pink Sheet
  2. >>Advanced Technologies
  3. >>Cell & Gene Therapies

US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes

 
• By Sue Sutter

Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.

Tree branches
Some of the branches of FDA's Office of Tissues and Advanced Therapies have grown so large they are unmanageable. • Source: Alamy

The US Food and Drug Administration’s Office of Tissues and Advanced Therapies is eyeing an internal reorganization, as well as changes in how it interacts with sponsors, to help it keep up with the burgeoning workload involving cell and gene therapies.

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 Cell & Gene Therapies

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

More from Advanced Technologies

EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

 
• By Neena Brizmohun

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.