CDER plans new guidance on AI, electronic safety report submissions, and more
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new topics since the list was last updated in February.
Among the new additions are a new supplemental guideline on computer software assurance for artificial intelligence (AI)-based systems in drug manufacturing and clinical investigations, as well as new guidance on unbranded biologics, pharmacokinetic (PK) criteria for alternate dosing and routes of administration for Fc-containing protein products, and electronic submission of postmarketing safety reports. (RELATED: FDA’s CDER agenda includes new guidance on digital health technologies and AI in manufacturing, Regulatory Focus 25 February 2026)
The agenda outlines a total of 85 upcoming guidance documents, many of which were carried over from the previous agenda. It covers 14 topics, including artificial intelligence, biosimilars, clinical and medical issues, clinical pharmacology, generics, as well as pharmaceutical quality and chemistry, manufacturing, and controls (CMC).
Many of the upcoming new and revised guidelines focus on generic drugs. Some of the planned documents will cover assessing adhesion for transdermal delivery systems, evaluating qualitative (Q1) and quantitative (Q2) sameness for Abbreviated New Drug Applications (ANDAs), examining the irritation and sensitivity potential of transdermal and topical delivery systems for ANDAs, and conducting bioavailability and bioequivalence studies for nasal products.
Other documents include a guidance on engaging with FDA to discuss the use of digital health technologies in clinical investigations for drugs and biologics in the administrative and procedural category; guidance on information to submit to support safety evaluations in the clinical and medical category; and guidance on the study of pharmacokinetics in pregnancy.
CDER also plans to publish three guidance documents developed by the International Council for Harmonisation (ICH) this year. These documents include the Q3C(R10) guidance on maintenance of the guidance for residual solvents, the Q6(R1) revision of the Q6A and Q6B specification guidelines, and the S13 guideline on nonclinical safety studies or oligonucleotide-based therapies.
CDER noted that it is not required to follow this list and may issue new guidance that is not included in it.
