...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...efficacy studies in humans ethically cannot be conducted. This rule would establish standards for using wellcontrolled animal trials when the results of those...

...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...Studies in Humans Ethically Cannot Be Conducted). VDDI has developed a preclinical and clinical strategy in accordance with these new regulations, and...

...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...Efficacy Studies in Humans Ethically Cannot Be Conducted) This strategy will be discussed with FDA at the pre-IND meeting. The most rapid prc-lnvestigational...

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

...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...

...at www.jhsph.edu/magazine/model.htm. Food and Drug Administration. 1999a. "New Drug and Biological Products: Evidence Needed to Demonstrate Efficacy...Disabling Toxic Substances when Efficacy Studies in Humans Cannot Be Conducted." Federal Register. 64: 53,960 et seq. Food and Drug Administration. 1999b. "Supplementary...

...US law.1** 48. October 1999. The FDA and the DoD proposed to amend the law in a proposed rule, "A'ew Drug and Biological Drug Products; Evidence needed...Disabling Toxic Substances When Efficacy Studies in Human Ethically Cannot be Contiucleif'' . ' This amendment would allow evidence of effectiveness derived...