– FDA releases draft guidance on monoclonal antibodies in Dec 2025… “Avoiding unnecessary animal testing.”
– ‘ISTAND’ program for innovative technology support becomes permanent, institutionalizing Organoids and AI tools – Creation of medical AI regulatory sandboxes under the White House ‘AI Action Plan.’
The U.S. Food and Drug Administration (FDA) is significantly shifting its regulatory policies to reduce animal testing, which has been essential in drug development, by leveraging advanced alternative technologies such as organoids and Artificial Intelligence (AI). This move is interpreted as a measure to address ethical concerns while enhancing development efficiency.
■ Streamlined Nonclinical Studies for Monoclonal Antibodies… “Long-term Primate Studies Not Warranted”
In December 2025, the FDA’s Center for Drug Evaluation and Research (CDER) released a draft guidance titled “Monoclonal Antibodies: Streamlined Nonclinical Safety Studies. The core of this guidance is to avoid the unnecessary use of animals, particularly Non-Human Primates (NHPs), in the development of monospecific antibodies, consistent with the 3R principles (Reduce, Refine, Replace) of animal testing.
According to the guidance, long-term toxicity studies exceeding 3 months in non-rodent species (e.g., primates, dogs) are generally not warranted to evaluate the chronic toxicity of monospecific antibodies. Instead, these can be replaced by a “Weight-of-Evidence (WoE)” risk assessment that integrates mechanism of action, target biology, and clinical data. Notably, the FDA stated that this risk assessment may include data from “New Approach Methodologies (NAMs)” that can replace animal testing, officially opening the possibility of using organoids and AI models.
■ ‘ISTAND’ Program for Alternative Technologies Made Permanent
To institutionally support the adoption of innovative technologies replacing animal testing, the FDA has transitioned the “Innovative Science and Technology Approaches for New Drugs (ISTAND)” program from a pilot to a permanent qualification program.
According to industry trends in August 2025, the ISTAND program aims to officially qualify AI-based tools, Organ-on-a-chip, and digital health technologies as Drug Development Tools (DDT) for integration into regulatory science. During the pilot phase, numerous submissions included AI-based tools and preclinical safety assessment tools capable of replacing animal testing (such as novel tissue-related methods), demonstrating high industry interest. This suggests that AI and organ-on-a-chip technologies are establishing themselves as core infrastructures in drug development.
■ Building a Medical AI Ecosystem Linked to the White House AI Action Plan
These changes align with the U.S. government’s broader AI strategy. According to “America’s AI Action Plan,” released by the White House in July 2025, the FDA plans to establish regulatory sandboxes to facilitate the adoption of medical AI. This creates an environment where researchers and companies can rapidly test AI tools without immediate regulatory burdens, signaling innovation in the medical device approval process.
In particular, AI is playing a crucial role in replacing or complementing animal testing through toxicity prediction in the early stages of drug development. The industry views organoid technology as a key component of New Alternative Methods (NAMs) to reduce or replace animal testing, aligning with the trend of strengthening the 3Rs (animal welfare).
The FDA’s moves demonstrate that the drug development paradigm, which traditionally relied on animal testing, is rapidly reorganizing into a “Digital-Bio Convergence” system combining AI and biotechnology. Consequently, domestic pharmaceutical and biotech companies are expected to re-establish their nonclinical testing strategies and accelerate the acquisition of related technologies in line with global regulatory changes.