Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry

Description

The purpose of this guidance is to assist sponsors in the development of drugs for the indication of prophylaxis of 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 indication also applies to persons with anticipated exposure to B. anthracis spores (e.g., first responders for anthrax incidents); in such cases, initiation of antibacterial therapy would begin immediately before entering the B. anthracis-contaminated environment. For more information regarding the indication, see section II.B., Indication for Prophylaxis of Inhalational Anthrax.

Scope & Applicability

Regulatory Context

• 21CFR314.610§ 314.610 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a new drug product for which safety has been established and for which the requirements of § 314.600 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the drug product is reasonably likely to Read full regulation →

• 21CFR601.91§ 601.91 Approval based on evidence of effectiveness from studies in animals.

  (a) FDA may grant marketing approval for a biological product for which safety has been established and for which the requirements of § 601.90 are met based on adequate and well-controlled animal studies when the results of those animal studies establish that the biological product is reasonably likRead full regulation →

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

• Investigational Device Exemptions (Clinical Investigator)

  Mobeen Mazhar, M.D.

  2023-06-06

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