REGULATORY UPDATE: FDA Releases 2023 Guidance Agenda

The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has released the guidance agenda for 2023, which includes topics CBER is considering for development during the calendar year.

In the category of “Blood and Blood Components,” CBER lists six documents, including the guidance on individual risk assessment issued last week. Three guidance documents are carried over from 2022, including an updated title for the “Alternative Procedures for the Manufacture of Cold-Stored Platelets” draft guidance. The 2023 agenda also includes a new draft guidance on testing blood donations for hepatitis B surface antigen (HBsAg), which the blood community asked FDA to address in a June 2022 joint letter.

The six documents listed are:

• Collection of Platelets by Automated Methods; Guidance for Industry (carried over from 2022).
• Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry (issued January 2023).
• Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical; Draft Guidance for Industry (revised title).
• Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry (carried over from 2022).
• Blood Pressure and Pulse Donor Eligibility Requirements; Compliance Policy; Draft Guidance for Industry (carried over from 2022).
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen; Draft Guidance for Industry (new).

In the category of “Tissues and Advanced Therapies,” CBER plans five guidances. The list includes two new guidances and three guidances carried over from 2022.

The five guidances are as follows:

• Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry and Staff (carried over from 2022).
• 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Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Draft Guidance for Industry (new).
• Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry (new).
• Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (carried over from 2022).
• Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry (carried over from 2022).

The AABB Newsfeed will include additional information as FDA releases these guidances. Members with questions may contact regulatory@aabb.org.