Overview
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities, suggesting where industry stakeholders might encounter new oversight-related opportunities and challenges in the coming year. These guidance agendas are not set in stone, however. Because all were published in the last days of the Biden administration, the emerging Trump administration FDA will likely direct units to publish updated versions reflecting changed priorities in the near future.
Five of FDA’s centers and offices published their CY 2025 guidance agendas in early to mid-January: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Oncology Center of Excellence (OCE), the Office of the Chief Scientist (OCS), and the Office of the Chief Medical Officer (OCMO). The centers’ agendas anticipate more than 170 total guidance documents that will cover a wide range of impactful topics, including compounding, cell and gene therapy products, and clinical trial operations.
In Depth
Despite the impressive breadth of topics covered by the various guidance agendas, some overarching trends and priorities are apparent. For example, guidance related to clinical trials and study design has been slated to receive a significant amount of attention in CY 2025, with CDER, OCE, and OCMO all prioritizing drafts related to these topics. Examples include the following:
| Guidance | Type | Issuing Center |
| Master Protocols for Drug and Biological Product Development | Revised Draft | CDER |
| Informative Bayesian Methods in Pediatric Clinical Trials | Draft Guidance | CDER |
| Considerations for the Inclusion of Older Adults in Clinical Trials | Draft Guidance | CDER |
| Clinical Pharmacogenomics: Evaluation, Study Design, and Analysis | Draft Guidance | CDER |
| Approaches to Assessment of Overall Survival in Oncology Clinical Trials | Draft Guidance | OCE |
| Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Research | Draft Guidance | OCMO |
Biosimilars and biologics have also been slated for attention in CY 2025. CDER and CBER have identified opportunities to draft and finalize guidance on subtopics such as the following:
| Guidance | Type | Issuing Center |
| Pediatric Study Plans for Biosimilar Products | Draft Guidance | CDER |
| Scientific Considerations in Demonstrating Biosimilarity to a Reference Product | Revised Draft | CDER |
| Considerations for the Use of Human- and Animal-Derived Materials in Cell and Gene Therapy | Final Guidance | CBER |
| Clinical Pharmacogenomics: Evaluation, Study Design, and Analysis | Draft Guidance | CDER |
| Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products | Final Guidance | CBER |
The omission of certain topics from the units’ guidance agendas is of equal note. New guidance related to artificial intelligence (AI) standards did not appear on any January 2025 agendas. However, the Center of Devices and Radiological Health’s agenda, published in October 2024 (and discussed in this On the Subject) included two AI-related guidances. Additionally, the Biden administration issued two much-anticipated draft guidance documents in January 2025 addressing the use of AI in drugs and devices. McDermott will closely monitor this area as the Trump administration decides whether to adopt a novel approach to AI governance.
CDER
CDER’s CY 2025 guidance agenda spans 15 topic areas, including labeling, pharmaceutical quality, current good manufacturing practices, compounding, and generics.
The agenda places particular emphasis on providing industry stakeholders with information and resources related to abbreviated new drug applications (ANDAs) for generic drug products. Planned ANDA-related guidance will cover topics such as submission content and formatting, general considerations for ANDAs in the pediatric exclusivity context, and frequently asked questions (FAQs) on refuse-to-receive standards.
CDER also plans to develop several guidance documents discussing allowable compounding practices under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
CBER
The CBER CY 2025 guidance agenda focuses on two main categories: therapeutic products, and blood and blood components. Within the therapeutics category, CBER expects to draft and finalize a suite of guidances helping stakeholders navigate various aspects of cell and gene therapy product regulation. Forecasted publications include FAQs related to cell and gene therapy products, and documents covering accelerated approval of gene therapy products for rare diseases.
OCE
Although OCE does not typically publish an independent regulatory agenda, it opted to do so for CY 2025. Its agenda lists several highly important guidances for stakeholders in the oncology space, including “Approaches to Assessment of Overall Survival in Oncology Clinical Trials” and “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.”
OCS
The OCS CY 2025 guidance agenda is centered on two key topics: cosmetic products and ethical standards for FDA advisory committees. The guidance documents related to cosmetic products will address mandatory recalls and records access and are being developed in concert with the FDA Office of Inspections and Investigations.
OCMO
The OCMO CY 2025 guidance agenda touches on subjects related to clinical trials, combination products, medical products, and rare diseases. OCMO expects to issue final guidance titled “How to Prepare a Pre-Request for Designation (Pre-RFD)” as well as several new draft guidances, including an overview of the orphan drug designation program.
In addition to inviting general comments on the substantive topic areas covered by each of the proposed guidance documents, CDER, CBER, OCE, OCS, and OCMO request stakeholder comments on how the guidance documents should be prioritized internally.
* * * * * *
THE McDERMOTT DIFFERENCE
McDermott will continue to monitor any changes the Trump administration makes to the centers’ and offices’ guidance agendas. If you are interested in submitting comments to any of the above centers or have questions about how the CY 2025 guidance agendas could impact your business, please contact a member of McDermott’s Food, Drug & Medical Device Regulatory Group.
