Abstract
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s regulatory response to public health crises. This review presents some examples of our diverse scientific work undertaken in recent years to support our regulatory and public health mission.
Highlights
The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has regulatory oversight of blood, tissues, and complex medical products that include vaccines, allergenic products, blood-derived products, certain diagnostics and devices, live biotherapeutics, and novel medical products, such as stem cell-derived products, and other cell and gene therapies.The complex biological products regulated by CBER present a variety of challenges:(1) The challenge of ensuring product sterility, i.e., the absence of unwanted infectious agents, is compounded with the use of biological materials in the manufacture of biological products
The complex biological products regulated by CBER present a variety of challenges: [1] The challenge of ensuring product sterility, i.e., the absence of unwanted infectious agents, is compounded with the use of biological materials in the manufacture of biological products
A recent example of the work being performed by the consortium is the development of a new method to predict differentiated functional capacity of human mesenchymal stem cells after osteogenic induction
Summary
This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s regulatory response to public health crises. This review presents some examples of our diverse scientific work undertaken in recent years to support our regulatory and public health mission
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