17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century medicine.

Many of the products regulated by CBER are either living cells or tissues, or are made from them, such as stem cells and genetically engineered immune cells. The Center’s diverse regulatory portfolio of complex biological products includes blood components and derivatives, vaccines, allergenics, and cellular and gene therapies. It also includes certain devices, including in vitro diagnostic tests for screening the blood supply and devices for the manufacturing of blood and tissue products.

The safety and efficacy of the biological products regulated by the FDA are inextricably linked to the quality and consistency of their manufacturing. This is as true now as it was when the Biologics Control Act of 1902 was enacted. Over a century of experience has informed our development of a holistic approach to the development and regulation of these products, from facilitating preclinical development to clinical development and on to post-market surveillance. This approach acknowledges the critical link between quality manufacturing and controls and the safety and efficacy of the products. To put it simply, for patients and the public to benefit from biological products, they must be made well.

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