BioCentury
ARTICLE | Regulation

Understanding accelerated approval

September 17, 2001 7:00 AM UTC

Accelerated approval will be considered when approval "can be reliably based on evidence of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients."

- Federal Register, Dec. 11, 1992...