Expanded availability of investigational new drugs through a parallel track mechanism for people with AIDS and other HIV-related disease--PHS. Notice final policy statement.
The Public Health Service (PHS) is announcing a final policy to make promising investigational drugs for AIDS and other HIV-related diseases more widely available under "parallel track" protocols while the controlled clinical trials essential to establish the safety and effectiveness of new drugs are carried out. The "parallel track" initiative establishes an administrative system designed to expand the availability of promising investigational agents and to make these agents more widely available to people with AIDS and other HIV-related diseases who have no therapeutic alternatives and who cannot participate in the controlled clinical trials.
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D026683:Advisory Committees; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000592:standards*; D015507:Drugs, Investigational / Q000592:standards* / Q000600:supply & distribution; D004608:Eligibility Determination; D026724:Ethical Review; D035082:Federal Government; D033161:Government Regulation; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D018579:Patient Selection; D035842:Research Subjects; D036302:Therapeutic Human Experimentation; D014481:United States; D014492:United States Public Health Service; D035862:Vulnerable Populations
D015507:Drugs, Investigational