CBER outlines its guidance priorities for 2026
The Center for Biologics Evaluation and Research (CBER) has published a list of the guidances it is considering publishing during 2026. They include guidances on chimeric antigen receptor (CAR) T cells, a slew of guidances for cell and gene therapy (CGT) products, and products for collecting blood and blood components.On 9 January, CBER published its list of guidance priorities focusing on three areas, including blood and blood components, therapeutic products, and vaccines and allergenics. The agency proposed developing 35 guidances, with 19 of them focusing on therapeutic products.
FDA said it plans to finalize several guidances related to therapeutic products, including its guidances on frequently asked questions on CGT products guidance, considerations for human- and animal-derived materials and components when developing CGT products, and CAR-T products for non-oncology indications.
Five of the guidances focus on blood and blood component products, including a guidance on the development of blood collection, processing, and storage systems to manufacture blood components using the buffy coat method. The method uses centrifugal force to separate different blood components.
Several of the guidances also address hepatitis viruses. CBER is considering developing a guidance on testing blood donations for hepatitis, and guidances on reducing the risk of hepatitis B and C in CGT products.
CBER stated that it is also considering publishing guidances on chemistry, manufacturing, and controls (CMC) requirements for investigating allergenic products for food allergies.
The agency also said it plans to develop guidance on evaluating combination vaccines, the data needed to support the development of COVID-19 and influenza vaccines, and developing vaccines for use by pregnant women.
Additionally, CBER said it will look to develop guidances on the standardized format of electronic marketing application submissions when planning Bioresearch Monitoring (BIMO) inspections, and validating and implementing alternative microbial methods to test biologics.
CBER guidance agenda
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