FDA is announcing the availability of a guidance for industry entitled “Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.” The purpose of this guidance is to assist sponsors in the development of new drugs to be administered to people who have or may have inhaled Bacillus anthracis spores, but who have not yet manifested clinical evidence of disease, to prevent the development of inhalational anthrax. This guidance clarifies that drugs for the prophylaxis of inhalational anthrax are to be considered for approval under the animal rule regulations because human efficacy trials are not ethical or feasible (21 CFR part 314, subpart I, for drugs, and 21 CFR part 601, subpart H, for biological products).
This guidance finalizes the draft guidance of the same name issued on February 16, 2016 (81 FR 7813). Changes made to the guidance took into consideration written and verbal comments received. In addition to changes primarily for clarification, the major changes are as follows: clarity in defining specific populations that would receive a drug for prophylaxis of inhalational anthrax, for example, first responders who anticipate exposure to Bacillus anthracis spores and initiate drug therapy immediately before exposure. In addition, the guidance was updated to provide consistency with the guidance for industry entitled “Product Development Under the Animal Rule”.
For more information, please visit: Anthrax Guidance for Industry.