CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System
Executive Summary
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
You may also be interested in...
US FDA’s Gene Therapy Office Poaches OCE’s Fashoyin-Aje For Oncology Position
Lola Fashoyin-Aje, formerly associate director of the Oncology Center of Excellence, will become director of the CBER Office of Therapeutic Products’ Office of Clinical Evaluation.
CBER Will Devote More Time To Non-COVID-19 Work Beginning In Six Months
Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes
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.