Cancer Patients Gain Say in Drug Approvals --- FDA and Drug Makers Add Reports From Trial Participants To Traditional ... (Women's Cancer Network)
A cancer drug's effectiveness has long been measured in two important ways: whether it shrinks a tumor and whether it extends patients' lives. But researchers and regulators are paying increasing attention to another criterion: how a patient feels while taking the medicine.

Edwards Lifesciences Comments on FDA Warning Letter (PR Newswire via Yahoo! Finance)
Edwards Lifesciences Corporation announced today that it has received a warning letter from the Los Angeles District Office of the U.S. Food and Drug Administration resulting from an inspection of Edwards' facility in Irvine, Calif., that concluded in August 2006.