FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both new and revised guidance documents. This latest agenda features several additions to the agency's list.

Since last year, the agenda has included new guidelines on how to interact with the FDA concerning the use of digital health technologies in clinical investigations of drugs and biological products. Additionally, it features new guidance on the application of artificial intelligence (AI) and machine learning (ML) in pharmaceutical manufacturing. (RELATED: CDER announces new guidance agenda for 2025, Regulatory Focus 23 January 2025)

The agenda includes 81 guidelines that are scheduled for release, many of which are carried over from the January 2025 agenda. It covers 12 topics, including biosimilars, clinical and medical issues, compounding, generics, labeling, and pharmaceutical quality, chemistry, manufacturing, and controls (CMC). As in previous years, this year's agenda emphasizes generic drugs, with 26 of the topics focusing specifically on them.

This year's agenda also includes at least 15 new items. Among the new additions are three guidelines in the administrative category: engaging with the FDA to discuss the use of digital health technologies in clinical investigations of drugs and biological products; guidance on expedited programs, including fast track, breakthrough therapy, and priority review; and a revised guidance on drug and device manufacturer communications with payors, formulary committees, and small entities.

Three new guidelines have been added to the biosimilars category: a revised draft on biosimilar and interchangeable biosimilar insulin products, labeling requirements for biosimilar and interchangeable products, and new and revised draft Q&As regarding biosimilar developments and the Biologics Price Competition and Innovation Act of 2009.

One new guideline has been added to the clinical category on developing products for sickle cell disease.

Two new additions have been added to the generics category regarding the assessment of qualitative (Q1) and quantitative (Q2) sameness for abbreviated new drug applications (ANDAs), as well as considerations for developing generic peptide products.

New guidance has been added in the pharmaceutical quality/CMC category regarding AI/ML quality considerations in pharmaceutical manufacturing. Additionally, a new guidance has been added on distributed manufacturing application content.

One of the more notable guidance documents set to be released this year in the administrative category is a guidance on national drug codes (NDC) for human drugs, including biological products.

FDA is under pressure from pharmaceutical industry groups, drugmakers, and other industry stakeholders to finalize its proposed rule to update the format of the NDC by the end of March 2026. (RELATED: Pharma groups pressure FDA to finalize NDC rule, Regulatory Focus 18 February 2026)

Another notable document set to be released this year is guidance on the Commissioner’s Priority Review Voucher Programs. The agency has yet to release guidance on the program, which was announced in June 2025 to accelerate reviews of products that align with national priorities. (RELATED: FDA announces new voucher program for drugs tied to national priorities, Regulatory Focus 17 June 2025)

CDER said that it is not obligated to follow this list and may issue guidance documents that are not included. Additionally, differing priorities from the Trump administration could influence the documents that are ultimately published.

Agenda

FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing

Related topics

Recommended content

Welcome to the new RAPS Digital Experience