HHS milestones

• Investing in Infrastructure for Human-Based Research

  September 21, 2026
  NIH

  Announced an investment of more than $88 million in funding for biomedical infrastructure projects to support human-based science nationwide.

• Building a Human-Based Research Lab

  September 21, 2026
  NIH

  Announced plans to build a state-of-the-art laboratory at the NIH Clinical Center that will integrate standardized human organoid models, robotics, artificial intelligence, and advanced data capabilities to enable experiments on reproducible human biological systems.

• Recruiting Human-Based Science Experts

  September 21, 2026
  NIH

  Launched an initiative to recruit grant reviewers with expertise in human-based science.

• Tracking Animal Use in NIH Research

  September 21, 2026
  NIH

  Issued a new request for information from the scientific community to assess the feasibility of an annual public report tracking the number of vertebrate animals used in NIH-funded research.

• Updating Nonclinical Testing Terms

  September 21, 2026
  FDA

  Issued a direct final rule replacing certain references to “animal tests” and “animal studies” with broader “nonclinical” terminology, facilitating and encouraging movement away from animal models where possible.

• Sharing Practical Examples of NAMs

  September 21, 2026
  FDA

  Published a New Approach Methodologies (NAMs) Database of Use Case Examples described in publicly available FDA application review materials.

• Advancing Human-Based Research Models

  September 21, 2026
  FDA

  Selected American Type Culture Collection (ATCC) to advance NAMs, including microphysiological systems (MPS) and organoid-based platforms, for infectious disease and cancer research.

• Advancing Quantum Tools for NAMs

  September 17, 2026
  NIH

  A new challenge offering more than $7 million in awards to demonstrate how quantum-enabled approaches can improve detection and measurement in lab-based New Approach Methodologies (NAMs).

• Advancing Women’s Health Modeling

  September 14, 2026
  NIH

  Awarded $21M for a program supporting human-based computational modeling of hormone homeostasis with specific application to women’s health.

• Reviewing In Vitro NAMs at FDA

  September 9, 2026
  FDA

  Published an analysis of how in vitro New Approach Methodologies (NAMs) have been used in drug development studies submitted to FDA.

• Advancing Biologics Safety Testing

  September 1, 2026
  FDA

  Held a Center for Biologics Evaluation and Research (CBER) workshop on Next-Generation Sequencing (NGS) for detecting unwanted biological agents in biologic products.

• Improving Research and Safety Tools

  August 11, 2026
  NIH

  Launched new versions of tools to provide access to validated alternative methods and to provide chemical safety data and property predictions.

• Integrating NAMs into Safety Testing

  July 28, 2026
  FDA

  FDA–HESI–Safety Pharmacology Society hybrid workshop on NAMs integration into safety pharmacology.

• Investing in Human-Based Cancer Research

  July 28, 2026
  NIH

  Directed $15M for a technology development center to predict cancer patient responses using human-based science.

• Coordinating NAMs Across FDA

  July 1, 2026
  FDA

  Established FDA’s NAMs Steering Committee to guide and coordinate New Approach Methodologies across the agency.

• Modernizing Drug Tool Qualification

  July 1, 2026
  FDA

  Completed the move of all Drug Development Tool (DDT) Qualification Program activities to FDA’s OneNexus Platform.

• Establishing NAMs Qualification Task Force

  July 1, 2026
  FDA

  Established a new International Liaison Group on Methods for Risk Assessment of Chemicals in Food (ILMERAC) NAMs Qualification Task Force, co-chaired by FDA and the German Federal Institute for Risk Assessment (BfR).

• Evaluating an Anticaries Test Model

  July 1, 2026
  FDA

  Requested data on a pH cycling test model for evaluating over-the-counter anticaries drug products.

• Created New NIH Office

  June 15, 2026
  NIH

  Launched ORIVA—a new office dedicated to speeding the development and use of human-based research technologies across NIH.

• Advancing QSP-Based Dose Selection

  June 1, 2026
  FDA

  Issued draft guidance on using quantitative systems pharmacology (QSP) to support dose selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) trials.

• Streamlining Oncology Safety Studies

  May 1, 2026
  FDA

  Issued draft guidance to streamline nonclinical safety studies for certain oncology biologics and conjugated products.

• Reporting Progress on Animal Testing

  April 20, 2026
  FDA

  Published a progress report on reducing animal testing in nonclinical studies and outlined FDA’s next steps.

• Reducing Animal Testing in Preclinical Safety Studies

  April 10, 2026
  FDA

  Published a roadmap that outlines a strategic, stepwise approach for FDA to reduce and replace animal testing in preclinical safety studies of drugs and biologics with scientifically validated new approach methodologies (NAMs).

• Coordinating NAMs Across CDER

  April 1, 2026
  FDA

  Established New Approach Methodologies Coordinating Committee (NAMs CC) to support coordination across the Center for Drug Evaluation and Research (CDER).

• Piloting Integrated NAMs Review

  April 1, 2026
  FDA

  Launched a six-month pilot of Center for Drug Evaluation and Research’s (CDER) New Approach Methodologies Integrated Review Team (NAMs-IRT) to support the review of NAMs.

• Investing in New Approach Methodologies

  March 18, 2026
  NIH

  Announced $150 million investment to facilitate NAM development in the areas of greatest scientific and regulatory need.

• Guiding NAMs in Drug Development

  March 18, 2026
  FDA

  Issued draft guidance on general considerations for using New Approach Methodologies (NAMs) in drug development.

• Updating Pyrogen and Endotoxins Testing Guidance

  March 18, 2026
  FDA

  Updated guidance on pyrogen and endotoxin testing, including approaches that can reduce reliance on animal testing.

• Advancing Computational Toxicology

  March 1, 2026
  FDA

  Established an FDA-NIH-ARPA-H collaboration to develop toxicology databases and computational approaches through CATALYST.

• Reducing Reliance on Animal Testing

  February 26, 2026
  FDA

  Held a public meeting on advancing drug development while reducing reliance on animal testing through FDA’s Reagan-Udall Foundation.

• Reestablishing the NAMs Workgroup

  January 1, 2026
  FDA

  Reestablished FDA’s agency-wide NAMs Program Workgroup to coordinate and advance New Approach Methodologies across FDA.

• Streamlining Antibody Safety Studies

  December 2, 2025
  FDA

  Issued draft guidance on streamlined nonclinical safety studies for certain monoclonal antibodies.

• Reviewing NAMs in Drug Development

  December 1, 2025
  FDA

  Published a Center for Drug Evaluation and Research (CDER) review of New Approach Methodologies (NAMs) submitted as part of drug development programs.

• Qualifying an AI-Based Drug Tool

  December 1, 2025
  FDA

  Qualified the AI-Based Histologic Measurement of NASH (AIM-NASH) as FDA’s first AI-based drug development and evaluation tool.

• Reviewing CDER’s Experience with NAMs

  November 1, 2025
  FDA

  Published a systematic review of Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND) using New Approach Methodologies (NAMs) in drug development.

• Advancing Liver-on-a-Chip Research

  November 1, 2025
  FDA

  Published research on challenges and solutions for measuring commonly used biomarkers for drug-induced liver injury in a liver-on-a-chip platform.

• Encouraging Experimental Animal Retirement

  October 1, 2025
  NIH

  Changed NIH policy to allow grant funding to be used for retiring or rehoming animals.

• Embracing Streamlined Nonclinical Studies and Acceptable NAMs

  October 1, 2025
  FDA

  Published an online table containing an inventory of drug development contexts for which the Center for Drug Evaluation and Research (CDER) is open to a streamlined nonclinical program.

• Reducing Reliance on Animal Models

  September 25, 2025
  NIH

  Announced $87 million investment to create the first dedicated organoid development center to reduce reliance on animal tests.

• Creating an FDA-NIH Partnership on NAMs

  August 26, 2025
  FDA

  Established partnership between FDA and NIH to advance New Approach Methodologies (NAMs) and support alternatives to animal testing.

• Advancing Alternative Testing Models

  August 15, 2025
  NIH

  Included the development of alternative testing models as a key priority in the Director’s Unified Strategy.

• Making ISTAND Permanent

  July 31, 2025
  FDA

  Made the ISTAND (Innovative Science and Technology Approaches for New Drugs) Program permanent to support innovative drug development tools.

• Stopping Animal-Only Funding Opportunities

  July 10, 2025
  NIH

  Stopped issuing funding opportunities that exclusively support animal models.

• Meeting on Reducing Animal Testing

  July 7, 2025
  FDA

  Convened workshop focused on implementing novel methodologies and other strategies to reduce the use of animal testing.

• Ending Taxpayer-Funded Animal Experiments

  May 28, 2025
  NIH

  Cut funding to a Harvard University lab for studies that included sewing the eyes of young monkeys shut.

• Closed NIH Dog Lab

  May 1, 2025
  NIH

  Announced the closure of the last beagle laboratory on NIH campus.

• Prioritizing Human-Based Research

  April 29, 2025
  NIH

  Launched animal testing reduction initiative, including training review staff and integrating experts on alternative methods into study sections.

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