Smallpox Drug Development May Get Boost From FDA
This article was originally published in The Pink Sheet Daily
Agency convenes workshop to discuss use of animal models to demonstrate efficacy.
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Smallpox has been eradicated for more than 30 years, but FDA isn't sure whether sponsors studying treatments in animals in case terrorists deliberately infected people can use substitute pathogens under the “Animal Rule.” The Antiviral Drugs Advisory Committee will weigh in on the issue.
When an FDA advisory panel gave its enthusiastic backing to the strategy for anthrax vaccine research developed by the agency's Center for Biologics Evaluation and Research, it also provided an important precedent for future applications of the "animal rule," which allows sponsors to conduct animal trials when human clinical trials would be impractical or unethical.