REGULATORY UPDATE: FDA Releases 2025 Guidance Agenda
January 03, 2025
This article has been updated to reflect guidances released Jan. 6.
The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has released its guidance agenda for 2025, which includes topics CBER is considering for development during the calendar year.
In the category of “Blood and Blood Components,” CBER lists five documents, including four carried over from 2024. Notably, a new draft guidance has been added, focusing on recommendations for evaluating the use of non-D1(2-ethylhexyl) phthalate (non-DEHP) materials.
The five planned documents are as follows:
In the category of “Therapeutic Products,” CBER plans 14 guidances. The list includes two new guidances with 12 carried over from 2024:
- Frequently Asked Questions — Cell and Gene Therapy Products; Guidance for Industry (issued in 2024 as a draft guidance).
- 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Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products; Guidance for Industry (issued in 2024 as a draft guidance).
- Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Guidance for Industry (issued in 2024 as a draft guidance).
- Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry (new in 2025).
- Accelerated Approval of Human Gene Therapy Products for Rare Diseases; Draft Guidance for Industry (carried over from 2024).
- Use of Platform Technologies in Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry (carried over from 2024).
- Potency Assessment of Therapeutic Vaccines; Draft Guidance for Industry (carried over from 2024).
- Post Approval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry (new in 2025).
- 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 (issued Jan. 6).
- 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 (issued Jan. 6).
- Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (issued Jan. 6).
- Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (issued Jan. 6).
- Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (issued Jan. 6).
- Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry (issued Jan. 6).
In the “Other” category, CBER plans two guidances:
- 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 (issued in 2024 as a draft guidance).
- Recommendations for Validation and Implementation of Alternative Microbial Methods for Testing of Biologics, Draft Guidance for Industry (new in 2025).
The AABB Newsfeed will include additional information as FDA releases these guidances. Members with questions may contact
regulatory@aabb.org.
