TY - GEN AU - Edgar,Harold AU - Rothman,David J TI - New rules for new drugs: the challenge of AIDS to the regulatory process SN - 0887-378X PY - 1991///0129 KW - Acquired Immunodeficiency Syndrome KW - drug therapy KW - Attitude to Health KW - Clinical Protocols KW - standards KW - Clinical Trials as Topic KW - Decision Making KW - Drug Industry KW - legislation & jurisprudence KW - Drugs, Investigational KW - Economics KW - Ethical Review KW - Ethics KW - Ethics Committees KW - Ethics Committees, Research KW - Federal Government KW - Government KW - Government Regulation KW - Health Policy KW - trends KW - History KW - Human Experimentation KW - Humans KW - Informed Consent KW - International Cooperation KW - Internationality KW - National Institutes of Health (U.S.) KW - Organizational Innovation KW - Patient Advocacy KW - Patients KW - Pharmaceutical Preparations KW - Physicians KW - Politics KW - Research KW - Research Design KW - Research Subjects KW - Risk KW - Risk Assessment KW - Scientific Misconduct KW - Social Control, Formal KW - Therapeutic Human Experimentation KW - United States KW - United States Food and Drug Administration KW - organization & administration N1 - Publication Type: Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't ER -