US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response
Executive Summary
CBER’s heavy COVID-19 workload is pushing other things to the side, causing delays in sponsor meetings and issuance of new guidance documents, and a slowdown in efforts to streamline development of individualized therapeutics, biologics center leaders tell BIO Digital 2020.
You may also be interested in...
US FDA’s New ‘N of 1’ Guidance Essentially A Down Payment On Critical Advice
Draft guidance will help sponsor-investigators working on individualized gene therapies. The focus on basic administrative and procedural aspects of interaction with the FDA leaves many policy and commercialization questions about how these personalized investigational products should be studied unanswered.
Separating Gene Therapy ‘Wheat’ From ‘Chaff’: CBER Facilitators Could Help Inexperienced Sponsors
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.
US FDA’s Biologics Center May Be Busier After Coronavirus Subsides, Director Says
Peter Marks suggests that cell and gene therapy, as well as other product sponsors will be seeking help with clinical trials stalled by the pandemic.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: