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# Anthrax Drug Development Guidance
- URL: https://www.fdaweb.com/anthrax-drug-development-guidance/
- Published: 2018-05-23T12:00:00.000Z
- Updated: 2026-09-15T00:07:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141515

FDA has published a guidance, *Anthrax: Developing Drugs for Prophylaxios of Inhalational Anthrax*, to assist sponsors in developing drugs with an indication of prophylaxis to inhalational anthrax in persons who have or may have inhaled aerosolized *Bacillus anthracis* spores but who have not yet manifested clinical evidence of disease. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070986.pdf?ref=fdaweb.com) says the indication also applies to persons with anticipated exposure to *B. anthracis* spores such as first responders for anthrax incidents.

The guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax are to be considered for approval under the animal rule, FDA says. The animal rule establishes a pathway for approving drug or biological products when human efficacy studies are not ethical or feasible.