ARTICLE | Regulation

A Bridge to Anthrax

FDA panel clarifies anthrax pathway; other animal rule indications uncertain

November 22, 2010 8:00 AM UTC

FDA's Vaccines and Related Biological Products Advisory Committee provided some clarity to companies developing treatments for post-exposure anthrax prophylaxis last week. But questions remain for other indications that are in development under FDA's Animal Rule.

The panel agreed with the agency that the general use prophylaxis (GUP) test is the best method for bridging efficacy data demonstrated in animals to serologic data in humans in order to identify clinical endpoints for animal tests of protective antigen (PA)-based vaccines to treat post-exposure anthrax...