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.
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CBER director Peter Marks also wants to work on rare disease gene therapy issues and increase hiring before the end of the year.
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.