FDA animal data efficacy rule
This article was originally published in The Tan Sheet
Executive Summary
Drugs may be approved for human use based solely on animal data in cases where human testing is not feasible or ethical, according to FDA final rule published in May 31 Federal Register. Under the reg, drugs used "to reduce or prevent the toxicity of chemical, biological, radiological or nuclear substances" may be approved for marketing "based on evidence of effectiveness derived only from appropriate animal studies and any additional supporting data," agency says. Reg is part of FDA's effort to help improve nation's ability to respond to emergencies, including terrorist events; notice comes shortly after Congress passed bioterrorism bill (1"The Tan Sheet" May 27, 2002, p. 18)...