New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted

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The Food and Drug Administration (FDA) is proposing to amend its new drug and biological product regulations to identify the information needed to provide substantial evidence of the efficacy of new drug and biological products used to reduce or prevent the toxicity of chemical, biological, radiological, or nuclear substances. This proposal would apply when the traditional efficacy studies in humans are not feasible and cannot be ethically conducted under FDA's regulations for adequate and well-controlled studies in humans. The agency is proposing this action because it recognizes the need for adequate medical responses to protect or treat individuals exposed to these lethal or permanently disabling toxic substances. DATES: Submit written comments by December 20, 1999.