...TO i- ra =5 ro E "- io Q •= QQ ^-S' ' On October 5, 1999, FDA proposed regulations describing the evidence needed to demonstrate efficacy of new drugs...use against lethal or permanently disabling toxic < §• ra substances when efficacy studies in humans cannot ethically be conducted. current explanations....

...5, 1999, issued a proposed rule to establish a mechanism for approving drugs and biological products for use against lethal or permanently disabling toxic substances when efficacy studies in humans ethically cannot be conducted. This rule would establish standards for using wellcontrolled...

...that may be used in biological warfare (published in the Federal Register Vol 64, No.192, (Oct. 1999: "Evidence Needed to Demonstrate Efficacy of New Drugs...Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted). VDDI has developed a preclinical and clinical strategy in accordance...

...use of animal data to provide efficacy data to support FDA approval when scientifically reasonable (Proposed Rule: New Drug and Biological Drug Products;...Demonstrate Efficacy of New Drugs for Use Against Lethal of Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted,...

...use of animal data to provide efficacy data to support FDA approval when scientifically reasonable (Proposed Rule: New Drug and Biological Drug Products;...Demonstrate Efficacy of New Drugs for Use Against Lethal of Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted,...

...the Federal Register Vol 64, No. 192 (Oct 1999: "Evidence Needed to Demonstrate Efficacy of New Drags for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted) This strategy will be discussed with FDA at the pre-IND meeting....

...complete the testing. It is prior to this Phase, and to a lesser extent the other Phases, that FDA's proposed rule "New Drug and Biological Drug Products;...Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted" would guide these discussions. These discussions take place at...

...subjects with a deadly organism to show the efficacy of the product; • Published the proposed rule "Evidence Needed to Demonstrate Efficacy of New Drugs...Disabling Toxic Substances when Efficacy Studies in Humans Ethically Cannot Be Conducted." This proposed rule would amend the new drug and biological product...

...ethical considerations prevent the use of human subjects. The proposed regulation is Docket No. 98N-0237 "New Drug and Biological Drug Products; Evidence Needed...Demonstrate Efficacy of New Drugs for Use Against Lethal of Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted...

...Start-Up: Windover's Review of Emerging Medical Ventures. 7.1: 20-30. Food and Drug Administration. 1999. "Proposed Rule. New Drug and Biological Drug Products;...Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted." Federal Register. 64.192 (Tuesday, October 5): 53690-53970....