Investigational new drug, antibiotic, and biological product applications; clinical hold and termination--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final regulation that provides additional grounds for placing an investigation on "clinical hold" and for terminating an investigational new drug application (IND). Under this rule, FDA may require sponsors to cease distributing an experimental drug in an open, nonconcurrently controlled investigation if any of several specified conditions exist. This final rule is part of the Public Health Service's(PHS's) efforts to make promising drugs widely available to people with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-related disease who lack satisfactory alternative therapies, while simultaneously ensuring that the adequate and well-controlled clinical trials essential to establishing a new drug's safety and effectiveness are expeditiously conducted.
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000592:standards; D004341:Drug Evaluation / Q000592:standards*; D015507:Drugs, Investigational / Q000592:standards* / Q000600:supply & distribution; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational