Comments on the Food and Drug Administration (FDA) Cardiac and Renal Drugs Advisory Committee Recommended Guidelines for the Conduct of Antianginal Drug Trials

Abstract

The recommendations made by the Food and Drug Administration’s (FDA) Cardiac and Renal Drugs Advisory Committee for the conduct of antianginal drug trials have been discussed at open public meetings during the presentations of the results of trials of the antianginal drugs to the FDA Cardiac and Renal Drug Advisory Committee members. It should, however, be recognized that FDA guidelines (formally published or evolved during Advisory Committee meetings) are recommendations, not rules. Other approaches, particularly in unstable angina, may be equally appropriate. Of importance is to meet with the FDA on a case-by-case basis, when drug development programs are being conceived and from time to time as the program is being carried out.