Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry entitled Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes" dated October 2004. The draft guidance provides sponsors or investigators, with criteria for testing the efficacy and safety of oxygen therapeutics as substitutes for red blood cells, and guidance on the design of clinical trials to assess risk/benefit ratio of such use. The draft guidance, when finalized, would supercede the "Points to Consider on the Safety Evaluation of Hemoglobin-Based Oxygen Carriers," dated August 27, 1990, and replaces the draft "Guidance for Industry: Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers" dated September 1997.