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FDA Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes DRAFT GUIDANCE

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Guidance for Industry DRAFT
Content:
This guidance document provides sponsors or investigators, with suggested 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.

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