The accelerated approval pathway, formally established by U.S. Food and Drug Administration (FDA) regulations in 1992 and later codified in statute in 1997, enables expedited access to medicines that address an unmet medical need for serious and life-threatening diseases and conditions, while preserving FDA’s high standards for safety and effectiveness. This pathway has provided timely access to treatments for HIV/AIDS, cancers and rare diseases, leading to better health outcomes for millions of patients.

Learn more about the accelerated approval pathway in this fact sheet from PhRMA.