Regulatory Issues
FDA to OK drugs using animal data
Published in Medical Letter on the CDC and FDA, June 23rd, 2002
The rules finalized May 30, 2002, will help in the development of bioterrorism antidotes to treat or prevent the potentially lethal or disabling toxicity of chemical, biological or nuclear substances. Traditional human testing of the drugs would be impossible.
"This isn't some kind of pass we're giving to these drugs," cautioned FDA drug chief Dr. Janet Woodcock, who said manufacturers will have to do several rigorous studies in animals and provide other supporting data.
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