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  1. Science & Research (Biologics)

Innovation and Regulatory Science

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CBER plays a critical role in the development of biological products that are at the cutting edge of 21st century medicine.

The center regulates preventive and therapeutic vaccines, blood and blood products, and cell, tissue, and gene therapies. Therefore, its research focuses on creating new knowledge in the fields of diagnostic and therapeutic product innovations and the regulatory science needed to ensure those products are safe, effective, and available to the public.

CBER scientists facilitate the development of new and promising biological products and technologies by increasing the understanding of existing products through mission-related research that advances regulatory science.  For example, CBER scientists are actively engaged in developing in vitro (“test-tube”) tests and animal models used to study new therapies and product testing methods, assays, and standards. This work supports the development of CBER-regulated products by enabling the development of manufacturing methods and providing tools to assess product safety, efficacy and manufacturing consistency.  CBER scientists also evaluate potential methods for improving ongoing monitoring of the safety of products that CBER has approved for use.

This web site provides both summaries of recently published research conducted by CBER scientists, posters developed to highlight some of this work, and examples of CBER research collaborations with other agencies, academic institutions, private organizations, and industry.  These web pages will keep you informed of current research being done at CBER that is helping to bring safe and effective products to the public.

Research Summaries and Scientific Posters older than 2 years are available on FDA Archive

Research Summaries

Scientific Posters

CBER Research Collaborations

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