US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response
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...
Draft guidance will help sponsor-investigators working on individualized gene therapies.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.
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.
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.