CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
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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.
PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.