In 1937, the release of “Elixir Sulfanilamide” without proper safety testing led to over 100 deaths due to the toxic solvent diethylene glycol. This tragedy prompted the U.S. Food and Drug Adminsitration to strengthen regulations, leading to the amendment of the Food, Drug, and Cosmetic Act in 1938, which mandated safety evaluations before product release, recognizing the importance of animal testing.

Over the next several decades,  there was an increase in global efforts advocating for safe and ethical testing procedures. Ultimately, this led to the passage of the FDA Modernization Act 2.0 in 2022, eliminating animal-testing mandates that were established in the early 1930s. Over a year later and there have not been any new updates on regulations, leading to the creation of the FDA Modernization Act 3.0. This was enacted in 2024, mandating the FDA to finalize rules for implementing FDAMA 2.0 which will allow for the development of safe and effective therapies without animal suffering.