The FDA’s Center for Biologics Evaluation and Research (CBER) has published its proposed guidance agenda for 2026, offering an early look at the regulatory areas that will shape biologics oversight in the coming year. The agenda highlights a strong focus on cell and gene therapies, blood and blood components, vaccines, and advanced manufacturing and inspection readiness.
For sponsors developing biologics, these priorities provide important signals about where regulatory expectations are evolving and where proactive planning may be required.
Strong Emphasis on Cell and Gene Therapies
A significant portion of CBER’s proposed guidance agenda centers on cell and gene therapy (CGT) products. Among the guidances under consideration are updates addressing frequently asked questions related to CGT development, considerations for human- and animal-derived materials used in CGT products, and regulatory expectations for CAR T-cell therapies beyond oncology indications.
These planned guidances reflect the continued expansion of CGT applications and the need for clearer regulatory frameworks to support product development, manufacturing controls, and lifecycle oversight as these therapies move into broader patient populations.
Blood and Blood Component Oversight
CBER’s agenda also includes multiple guidances related to blood and blood components. Proposed topics include the development of blood collection, processing, and storage systems, including systems that rely on the buffy coat method to separate blood components through centrifugation.
In addition, CBER is considering guidances related to infectious disease risk mitigation, including testing of blood donations for hepatitis viruses and reducing the risk of hepatitis B and C transmission in CGT products. These efforts underscore CBER’s ongoing focus on blood safety and supply chain integrity.
Vaccines, Allergenics, and Special Populations
Several proposed guidances focus on vaccines and allergenic products. CBER is considering guidance on the evaluation of combination vaccines, the data needed to support development of COVID-19 and influenza vaccines, and vaccines intended for use during pregnancy.
The agenda also includes potential guidance on chemistry, manufacturing, and controls (CMC) considerations for allergenic products developed to address food allergies, reflecting increasing interest in immunotherapies and preventative treatments in this space.
Manufacturing, Inspections, and Data Standards
Beyond product-specific topics, CBER plans to address cross-cutting regulatory areas such as standardized electronic submission formats used in planning Bioresearch Monitoring (BIMO) inspections and the validation and implementation of alternative microbial testing methods for biologics.
These initiatives point to continued modernization of inspection practices, data submission standards, and manufacturing quality expectations.
What This Means for Sponsors
CBER’s 2026 guidance priorities suggest that sponsors should expect increased regulatory clarity, but also heightened expectations, across CGT development, blood product safety, vaccine evaluation, and manufacturing controls. Organizations that monitor these developments early and align development strategies accordingly will be better positioned to manage regulatory risk and avoid delays.
How EMMA International Can Help
EMMA International supports biologics developers across the full product lifecycle, including regulatory strategy, CMC planning, CGT development support, inspection readiness, and submission strategy. Our teams help organizations anticipate regulatory change, interpret evolving guidance, and implement practical solutions aligned with FDA expectations.
As CBER advances its 2026 guidance agenda, EMMA partners with sponsors to translate regulatory priorities into actionable development and compliance strategies.
