Quality assurance and the drug development process: an FDA perspective.
Leonard
E M
EM
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland 20857.
D017277:Drug Approval / Q000458:organization & administration*; D004341:Drug Evaluation; D005544:Forecasting; D017387:Investigational New Drug Application; D009936:Organizational Innovation; D011785:Quality Assurance, Health Care; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration