Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions.In keeping with that mission CBER uses every tool available to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.ĬBER is working on multiple fronts to address the COVID-19 pandemic such as:
CBER also regulates selected drugs and devices used in the testing and/or manufacture of our biological products. This includes biological products such as prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products and live biotherapeutic agents. The mission of the FDA’s Center for Biologics Evaluation and Research (CBER) is to protect and promote the public health, in part by ensuring the safety and efficacy of the products we regulate. Letter to CBER Sponsors, Applicants and Regulated Entities on COVID-19 Please see the Letter to CBER Sponsors, Applicants and Regulated Entities. Submissions may be sent through the Electronic Submission Gateway or in some case by e-mail. CBER’s Document Control Center (DCC) will process paper and electronic media (CD/DVD, USB drive, etc.) submissions sent via U.S.
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