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Coronavirus (COVID-19) | CBER-Regulated Biologics

Collage of COVID-19 related images

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.  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.  CBER also regulates selected drugs and devices used in the testing and/or manufacture of biological products.  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.

Throughout the COVID-19 public health emergency, CBER worked on multiple fronts to address the pandemic, such as:

  • Expedited clinical trials for preventive vaccines and other therapeutic biological products that held promise to prevent or treat COVID-19 by providing timely advice and interactions
  • Supported product development and scale up of manufacturing capacity for high priority products for COVID-19
  • Helped to ensure an adequate blood supply
  • Provided information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products to treat patients with COVID-19

If you are developing or interested in developing a CBER-regulated product to treat or prevent COVID-19, including a vaccine, cellular product, or blood-derived product, this page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. 

If you are not a product developer and are looking for general information on FDA and coronavirus response efforts, you can review materials provided on FDA’s COVID-19 website

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