FDA Moving Beyond Animal Rule To Animal Guidance With November Workshop
This article was originally published in The Pink Sheet Daily
Focus will be on addressing regulatory challenges faced in developing countermeasures to chemical, biological and radiological threats.
You may also be interested in...
FDA’s Anti-Infective Drugs Advisory Committee will have new pharmacokinetic data to review when it meets Nov. 2 to discuss the monoclonal antibody, which targets the anthrax toxin rather than the pathogen.
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.