Interactive Timeline
1938 → 2022

84 Years of Regulatory Change

From mandating animal testing to ending the requirement: the history of drug safety regulation and the rise of New Approach Methodologies

84
Years of animal testing mandate
100M+
Animals used annually (pre-2022)
90%
Drug failure rate despite animal tests
2022
Year animal testing requirement ended

Federal Food, Drug, and Cosmetic Act

Response to Sulfanilamide disaster

After 107 people died from an untested toxic solvent in a sulfanilamide elixir, Congress passed the FD&C Act requiring pre-market safety testing. Section 505(i) established animal testing as the mandatory method for demonstrating drug safety before human trials.

Impact: For the next 84 years, every drug seeking FDA approval would require extensive animal testing, regardless of whether better alternatives existed.
1938
1966

Animal Welfare Act

First federal animal protection law

The Animal Welfare Act established minimum care standards for animals used in research, but explicitly exempted mice, rats, and birds - which comprise over 95% of animals used in drug testing. The act acknowledged concerns but didn't provide alternatives.

Impact: Created regulatory framework for humane treatment without questioning whether animal testing was scientifically necessary.

National Academy Report

"Toxicity Testing in the 21st Century"

The National Academy of Sciences released a landmark report calling for a paradigm shift away from animal testing toward human-relevant in vitro and computational methods. This report laid the scientific foundation for what would become New Approach Methodologies (NAMs).

Impact: Scientific consensus shifted: animal testing was increasingly seen as outdated, expensive, and often inaccurate at predicting human responses.
2007
2016

21st Century Cures Act

FDA modernization begins

This act encouraged FDA to consider alternatives to animal testing and established programs to evaluate new methodologies. It created pathways for breakthrough therapies and expanded the FDA's authority to accept innovative testing approaches, though animal testing remained the default requirement.

Impact: First legislative acknowledgment that alternatives to animal testing could be scientifically valid for regulatory decisions.

FDA Modernization Act 2.0

Animal testing mandate ends

Signed into law by President Biden on December 29, 2022, this historic legislation amended Section 505(i) to remove the 84-year-old mandate requiring animal testing. For the first time, drug developers could choose NAMs like organoids, organ-on-chip, and computational models for preclinical testing.

Impact: Revolutionary change - companies can now submit drugs for FDA approval without any animal testing data if validated NAMs demonstrate safety and efficacy.
2022
2023

FDA Modernization Act 3.0

Cosmetics testing ban

Building on FDA Mod Act 2.0, this legislation extended the principles to cosmetics, explicitly banning animal testing for cosmetic products and establishing NAMs as the preferred testing method for personal care products.

Impact: Complete industry transformation - cosmetics can no longer use animal testing, accelerating NAMs adoption across all consumer products.

Before 2022

  • Animal testing legally required for all drug approvals
  • 100+ million animals used in research annually
  • 90% of drugs still failed in human trials
  • 10-15 years average drug development time
  • $2.6 billion average cost per approved drug
  • Species differences caused unpredictable failures

After 2022

  • NAMs accepted as valid alternatives to animal testing
  • Human-relevant testing using organoids & organ-chips
  • Higher prediction accuracy with human tissue
  • Potential 50% reduction in development time
  • Significant cost savings with in silico screening
  • Personalized medicine via patient-derived testing

Learn More About the New Era

Dive deeper into the FDA Modernization Act and what it means for drug development

Complete FDA Guide NAMs Ecosystem Regulatory Hub