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.
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Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
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.
Just as COVID-19 work begins to wane, CBER’s Peter Marks expects an influx of gene therapy work as sponsors attempt to salvage clinical trials.