The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) released the 2026 guidance agenda on Friday, outlining topics the agency is considering for guidance development this year.
Blood and Blood Components
In the category of “Blood and Blood Components,” CBER lists five guidance documents, including two new planned guidance, one final version of a 2024 draft, one final version of a 2025 draft, and one carried over from 2025.
The planned documents are as follows:
- Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry (final of October 2024 draft).
- Collection of Platelets by Automated Methods; Draft Guidance for Industry (carried over from 2025).
- Recommendations for Testing Blood Donations for Hepatitis B Virus; Guidance for Industry (new in 2026).
- Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry (final of January 2025 draft).
- Recommendations for Testing Blood Donations for Human T-lymphotropic Viruses I and II; Draft Guidance for Industry (new in 2026).
As noted during the AABB’s 2025 “Ask the FDA” Annual Meeting session, the new “Testing Blood Donors for Hepatitis B Virus” final guidance is intended to consolidate all FDA recommendations for HBV testing into one guidance.
AABB, America’s Blood Centers and the American Red Cross previously requested that FDA reconsider its current recommendations for HTLV-I/II testing. Specifically, the organizations asked the agency to consider updating the testing requirement to one-time donor testing for antibodies to HTLV-I/II, coupled with effective leukoreduction of whole blood and blood components intended for transfusion.
Therapeutic Products
CBER’s 2026 agenda includes 19 guidances in the “Therapeutic Products” category, including six new guidances, 12 final versions of draft guidances issued between 2023 and 2025, and a reissued 2019 final guidance.
The planned guidances are as follows:
- Frequently Asked Questions — Cell and Gene Therapy Products; Guidance for Industry (final of November 2024 draft).
- Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Guidance for Industry (final of April 2024 draft).
- Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Guidance for Industry (final of April 2024 draft).
- Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry (final of December 2023 draft).
- Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry (new in 2026).
- Post-Approval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Guidance for Industry (final of September 2025 draft).
- Chimeric Antigen Receptor (CAR) T Cell Products: Development Considerations for Non-Oncology Indications; Draft Guidance for Industry (new in 2026).
- Considerations for Clinical Study of Porcine-Derived Solid Organs for Xenotransplantation; Draft Guidance for Industry (new in 2026).
- Considerations for Testing, Sampling and Archiving of Xenotransplantation Products; Draft Guidance for Industry (new in 2026).
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry (reissue of February 2019 final guidance).
- Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Guidance for Industry (final of July 2023 draft).
- Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry (new in 2026).
- Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of May 2025 draft).
- Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of May 2025 draft).
- Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of January 2025 draft).
- Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of January 2025 draft).
- Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of January 2025 draft).
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry (final of January 2025 draft).
- Establishing a Plausible Mechanism Supporting Approval of Individualized Therapies to Treat Rare Genetic Disorders; Draft Guidance for Industry (new in 2026).
Other
In the “Other” category, CBER lists two guidances, both of which are carried over from 2025:
- Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions; Guidance for Industry.
- Recommendations for Validation and Implementation of Alternative Microbial Methods for Testing of Biologics; Draft Guidance for Industry.
Vaccines and Allergenics
CBER also included nine guidances in the “Vaccines and Allergenics” category for 2026, covering allergenic products, vaccine manufacturing and clinical data requirements.
The AABB Newsfeed will include additional information as FDA releases these guidances. Members with questions may contact regulatory@aabb.org.
