title: How FDA currently makes decisions on clinical studies.
authors.affiliation: Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Rockville, MD 20857, USA. Temple@cder.fda.gov
authors.forename: Robert
authors.initials: R
authors.lastname: Temple
mesh_terms: D000328:Adult; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002227:Carbazoles / Q000627:therapeutic use; D000077261:Carvedilol; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods / Q000639:trends*; D003928:Diabetic Nephropathies / Q000517:prevention & control; D019317:Evidence-Based Medicine; D006333:Heart Failure / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D011412:Propanolamines / Q000627:therapeutic use; D013777:Tetrazoles / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration; D014633:Valine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068756:Valsartan
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002227:Carbazoles; D011412:Propanolamines; D013777:Tetrazoles; D000077261:Carvedilol; D000068756:Valsartan; D014633:Valine