The FDA's stance on advanced cellular therapy products

15 June 2023

Advanced cellular and tissue-engineered therapies offer ground-breaking opportunities for the treatment of diseases. Recent years have seen an uptick in the development and regulatory approval of revolutionary biological therapies across the globe.1

Within the US Food and Drug Administration (FDA), the Center for Biologics Evaluation and Research (CBER) regulates these biological products within the ambit of federal laws, like the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.2 It is CBER’s mission to safeguard public health by regulating biological products like vaccines, allergenics, tissues, and cellular and gene therapies.3

In March 2023, as a result of the reorganization of the Office of Tissues and Advanced Therapies, the CBER established a new super-office, the Office of Therapeutic Products (OTP).3 The aim of the OTP is to address challenges that arise with the recent boom in development of innovative biological products.3

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