1. Pink Sheet

CBER’s New Home For Gene Therapies: OTAT Changes To OTP But Leadership Questions Remain

 
• By Derrick Gingery

US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.

reorganization
Primary contacts for applications already under review will not change now that OTAT has been reorganized and renamed OTP. • Source: Shutterstock

The Office of Therapeutic Products now is in place within the US Food and Drug Administration’s Center for Biologics Evaluation and Research, although most of its senior positions are filled only temporarily.

OTP, formerly known as the Office of Tissues and Advanced Therapies (OTAT), was officially reorganized and promoted to super

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

More from Advanced Technologies

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By Kate Rawson

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.