WASHINGTON, D.C. — The U.S. Food and Drug Administration last week rolled out a sweeping slate of technology, enforcement, and approval actions that touch everything from artificial intelligence inside the agency’s own halls to opioid-like supplements on store shelves, experimental nerve scaffolds, livestock drugs, and cutting-edge cancer treatments.
In a move that could reshape how the FDA itself works, the agency on Monday said it has deployed “agentic AI” tools to all employees, enabling staff to build complex, multi-step AI workflows to support everything from pre-market review to inspections and post-market surveillance.
Agentic AI systems are designed to plan, reason and execute tasks toward specific goals, under built-in guidelines and human oversight. Participation is voluntary for staff, but Commissioner Marty Makary, M.D., M.P.H., said the timing is critical.
“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” Makary said. “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
The new tools build on “Elsa,” a large language model–based assistant the FDA introduced in May that is now used by more than 70 percent of staff. The agentic AI deployment is paired with a two-month internal “Agentic AI Challenge,” culminating in demonstrations at FDA Scientific Computing Day in January 2026.
Chief AI Officer Jeremy Walsh said the systems, which run in a high-security GovCloud environment and do not train on user inputs or industry submissions, will let reviewers streamline complex tasks while protecting sensitive data.
Animal Testing Cuts And New Drug Evaluation Tools
On Tuesday, the FDA took aim at long-standing animal testing practices, issuing draft guidance that could eliminate or sharply reduce six-month non-human primate toxicity studies for certain monoclonal antibody products.
The draft guidance is part of a broader roadmap to modernize nonclinical drug evaluation by integrating human-relevant models such as computational toxicology, organoids and real-world safety data in place of traditional animal studies.
“We are delivering on our roadmap commitment to eliminate animal testing requirements in drug evaluation and our promise to accelerate cures and meaningful treatments for Americans,” Makary said. He argued that more efficient, humane methods could shorten development timelines and cut research costs, potentially easing drug prices.
Richard Pazdur, M.D., who leads the Center for Drug Evaluation and Research, said the shift toward “knowledge-based risk assessment” will still rely on rigorous safety standards but will better reflect modern science. The agency plans to work with NIH, ICCVAM and international regulators to validate new methodologies and expand them to additional drug classes.
Crackdown On Opioid-Like Supplements
Also Tuesday, the FDA and Justice Department announced the seizure of about 73,000 units of products containing concentrated 7-hydroxymitragynine, or 7-OH, from three Missouri firms. The products, including liquid shots and tablets, were valued at roughly $1 million.
The agency said 7-OH, a substance that binds to opioid receptors, cannot lawfully be added to foods or dietary supplements and has not been approved for medical use. Such products are considered adulterated because they fail to meet safety standards.
“This enforcement action is a strong step to protect Americans from the dangers of concentrated 7-OH products, which are potent opioids,” Makary said. FDA Deputy Commissioner for Human Foods Kyle Diamantas, J.D., called the rise of 7-OH in supplements “of particular concern,” especially for youth.
Regulators noted they recommended scheduling certain 7-OH products under the Controlled Substances Act and previously issued warning letters to companies selling tablets, gummies, drink mixes and shots containing the ingredient.
Nerve Repair Breakthrough
On Wednesday, the FDA approved Avance (acellular nerve allograft-arwx), a cadaver-derived nerve scaffold designed to bridge damaged sensory nerves in adults and children as young as one month old. Under the Accelerated Approval pathway, the agency also cleared Avance for larger sensory gaps and for motor and mixed nerve injuries.
“Avance can bridge gaps in damaged nerves and support nerve function restoration,” said Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer and head of the Center for Biologics Evaluation and Research. He noted that current options, including autografts, often require surgeons to harvest healthy nerve tissue from elsewhere in the patient’s body, creating a second surgical site.
Avance uses specially processed cadaveric nerve tissue that preserves the natural structure guiding nerve regrowth. Acting Office of Therapeutic Products Director Vijay Kumar, M.D., said the agency exercised regulatory flexibility to expand indications based on a surrogate endpoint reasonably likely to predict benefit, with full approval contingent on confirmatory trials.
In a study comparing Avance to collagen nerve cuffs, the product met its primary endpoint for return of sensory function and was statistically non-inferior to the comparator. Common adverse reactions included procedural pain and heightened sensitivity to touch, temperature and pain. The product carries the theoretical risk of transmitting infectious agents, though no such cases have been identified.
Leadership Shift At Drug Center
Also Wednesday, the FDA named Tracy Beth Høeg, M.D., Ph.D., as acting director of the Center for Drug Evaluation and Research, elevating a physician-epidemiologist with a background in clinical practice, public health and evidence evaluation.
Makary said Høeg is “the right scientist to fully modernize CDER” and credited her work at the Center for Biologics Evaluation and Research on efforts to reduce and replace animal testing.
Høeg, who has published extensively in leading medical journals, called the appointment “an incredible opportunity to serve my fellow Americans,” pledging decisions grounded in rigorous science and a push to modernize evidence evaluation. The agency also named Karen Murry, M.D., director of the Office of Nonprescription Drugs to lead efforts to expand affordable over-the-counter options.
New Cattle Drug Targets Parasites And Food Supply Risks
On Thursday, the FDA conditionally approved Exzolt Cattle-CA1 (fluralaner) topical solution to prevent and treat New World screwworm larval infestations and to treat and control cattle fever tick in certain beef cattle and replacement dairy heifers.
Makary said the decision gives producers “a new tool to combat two parasites threatening the well-being of cattle in the U.S.,” noting that while New World screwworm has not been detected domestically, cattle fever tick is present. It is the first drug conditionally approved specifically for cattle fever tick.
Under conditional approval, Exzolt Cattle-CA1 must be shown to have a reasonable expectation of effectiveness for serious or life-threatening conditions, with up to five years for the sponsor, Intervet, Inc., to provide additional data. The drug received expedited review as a priority zoonotic animal drug under authorities from the CARES Act.
The topical, prescription-only product is applied along the dorsal midline from withers to tailhead. The slaughter withdrawal period is 98 days, and the product is not approved for lactating dairy cattle, veal calves or certain breeding bulls. Officials stressed that antiparasitic drugs should be used only when medically necessary and as part of a broader parasite management strategy.
First CAR T Therapy For Marginal Zone Lymphoma
In another major cancer milestone, the FDA on Thursday approved a new indication for Breyanzi (lisocabtagene maraleucel), making it the first CAR T-cell therapy authorized in the United States for adults with marginal zone lymphoma who have relapsed or failed at least two prior lines of therapy.
Breyanzi modifies a patient’s own T-cells to target and destroy cancer cells. Marginal zone lymphoma is a rare, slow-growing B-cell non-Hodgkin lymphoma that accounts for about 7 percent of such cases and has poor outcomes when initial therapy fails.
“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” Prasad said, adding that the agency is continuing to optimize its regulatory authority to expand treatment options.
In an open-label, multicenter trial, 66 of 77 enrolled patients received a single Breyanzi infusion following lymphodepleting chemotherapy. Of those treated, 95.5 percent responded, and 62.1 percent achieved a complete response with no signs of disease on imaging, with responses remaining durable at a median follow-up of 21.6 months. Common side effects included cytokine release syndrome, diarrhea, fatigue, musculoskeletal pain and headache.
Breyanzi received Priority Review and Orphan Drug designation. The approval was granted to Juno Therapeutics, Inc.
Digital Health Pilot Targets Chronic Disease At Home
Rounding out the week on Friday, the FDA unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a first-of-its-kind digital health program aimed at expanding access to technologies that help patients manage chronic diseases from home.
Developed by the Center for Devices and Radiological Health, the voluntary pilot will test a risk-based enforcement approach for digital tools used in cardio-kidney-metabolic, musculoskeletal and behavioral health conditions. Participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization, while they collect and share real-world performance data.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” Makary said, calling the model a potential lifeline for millions managing chronic illness.
The pilot is being launched in collaboration with the Centers for Medicare and Medicaid Services Innovation Center’s ACCESS model, which seeks to expand technology-enabled, integrated care. CMS Administrator Mehmet Oz, M.D., said insights from TEMPO will help shape future payment and care delivery models.
CDRH Director Michelle Tarver, M.D., Ph.D., said the program is designed to keep pace with rapid digital innovation through early engagement, “sprint” discussions and real-world data collection. The TEMPO pilot is a centerpiece of the FDA’s “Home as a Health Care Hub” initiative, which aims to bring more care into everyday settings.
Beginning in January 2026, the agency will solicit statements of interest and expects to select up to about 10 manufacturers in each of four clinical use areas, marking another step in a week that showcased the FDA’s increasingly aggressive embrace of technology, modernization and targeted enforcement.
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