Competitive Problems in the Drug Industry : Drug Testing: Summary and Analysis, Select Committee on Small Business, United States SenateU.S. Government Printing Office, 1979 - 142 pages |
Contents
Letter of Submittal | 1 |
FDA and the Drug Approval Process | 12 |
Selection of Drug Investigators and Payment | 34 |
8 other sections not shown
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Common terms and phrases
1st session 96th Congress adequate agency Alabama Amendments animal tests approved drugs assure bill Clinical Evaluation clinical investigations clinical pharmacology clinical testing clinical trials Commissioner concerning conducted congressional Cosmetic Act deficiencies DHEW Donald Kennedy Drug Administration Drug Application drug approval drug development drug firms drug industry drug investigations Drug Regulation Reform drug regulatory drug sponsor Drug Testing experience FDA's Federal Final Report Food and Drug Gaylord Nelson groups guidelines Hearings on Drug human subjects human test Ibid informed consent Institutional Review Boards institutional review committees investigational drug involved issue Kennedy laboratory legislation manufacturers molecular entities monitoring patients pharmaceutical industry Phase prison problems procedures proposed protection of human protocols Regulation Reform Act responsibility safety and effectiveness scientific Searle Senate specific standards statement Stough's test data test subjects testimony therapeutic gain U.S. Congress U.S. Govt Washington Welfare