Sponsor must demonstrate that the surrogate endpoint is plausibly linked to clinical outcomes
Predictor of disease progression and regression
FDA may require studies to demonstrate clinical benefit/validity of surrogate endpoint
Federal Register 57 (1992): 58942-58958
1962 Drug Amendments "No person shall introduce into interstate commerce any drug, unless they have demonstrated whether or not the drug is safe and effective for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof."
“ These sponsored [web] links make representations and/or suggestions about the efficacy of avandia … but fail to communicate any risk information. This omission of risk information is particularly concerning as… Avandia [has a] boxed warning.” -Michael Sauers [FDA] to GSK, March 26, 2009